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Completed Studies

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Completed Studies
Sr. No. Year Principal Investigator Study Title Phase Protocol No. Sponsor CRO Site Study Status
1 2007 Dr. M.S. Vishveshwara A Randomized, Double- Blind, Multicenter Study of Denosumab compared with zoledronic acid (Zometa) in the treatment of Bone Metastasis in subjects with advanced Cancer (Excluding Breast and Prostate cancer) or Multiple Myeloma III 20050136 Amgen PPD BHIO Closed
2 2007 Dr. M.S. Vishveshwara A Randomized, Double- Blind, Multicenter Study of Denosumab compared with zoledronic acid (Zometa) in the treatment of Bone Metastasis in subjects with Advanced Breast Cancer. III 20050244 Amgen PPD BHIO Closed
3 2007 Dr. Shekar Patil A Phase 2, Multi-center, Open label, Randomized study of Mapatumumab (TRM-1 [HGS1012], a fully monoclonal antibody to TRAIL R1) in combination with Bortezomib (Velcade) and Bortezomib alone in subjects with relapsed or refractory Multiple Myeloma” II HGS1012-C1055 HGS Paraxel BIO
BHIO
RGCI
AIIMS
Closed
4 2007 Dr. Shekar Patil A Randomized, multicenter therapeutic confirmatory study to evaluate the efficacy and safety of Proxinium plus best supportive care Verses best supportive care alone in patients with advanced Squamous Cell Carcinoma of Head and Neck who have received at least one Anticancer treatment regimen for advanced disease III VB 4-845-01-IIIA Viventia Pharma-Olam BIO Closed
5 2007 Dr. Shekar Patil A Randomized, DoubleBlind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men with Hormone-Refractory Prostate Cancer. III 20050103 Amgen PPD BIO Closed
6 2007 Dr. Shashidhara HP A phase III randomized trial of chemotherapy with or without Panitumumab in patients with Metastatic and / or recurrent Squamous cell carcinoma of the head and neck III 20050251 Amgen PPD BIO Closed
7 2007 Dr. Bhawana Awasthy Pilot Study: Differential Gene Expression Analysis of Selected Targets in Retrospective Human Pancreatic Ductal Adenocarcinoma IIT Triesta Sciences Closed
8 2007 Dr. Niti Narang A Phase ½ Modified Dose Escalation, Open Label Trial to determine the therapeutic Effect and Safety of INCB007839 combined with Trastuzumab in patients with previously untreated HER2 Positive Metastatic Breast Cancer II INCB7839-202 Incyte SIRO BIO Closed
9 2008 Dr. Niti Narang An Open-label, Randomized, Phase 3 Study of Inotuzumab Ozogamicin (CMC-544) Administered in Combination With Rituximab Compared to a Defined Investigator’s Choice Therapy in Subjects With Relapsed or Refractory,CD22-Positive,Follicular B-cell Non-Hodgkin’s Lymphoma III 3129K4-3301-WW Wyeth Pharmaceuticals GVK Bio BIO
CMCC
Closed
10 2008 Dr. Shekar Patil A Phase III Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated with Cisplatin Chemotherapy III 017-00 Merck GVK Bio BIO Closed
11 2008 Dr. Shekar Patil A Phase2 Safety and Efficacy Study of Bavituximab+Paclitaxel and Carboplatin in Patients with previously untreated locally Advanced or Metastatic Non-Small Cell Lung Cancer II PPHM – 0701 Perigrene Clinigene BIO Closed
12 2008 Dr. Ravi Diwakar An Open Label Randomized Comparative Multicentric Study to Assess Safety and Efficacy of BIOMab – EGFR (Nimotuzumab) in Combination with Chemotherapy versus Chemotherapy alone in the Treatment of Patients with stage IIIB/IV Non Small Cell Lung Cancer (NSCLC). III CLG032/BIO013/NSCLC/h-R3/2008 Clinigene BIOCON BIO closed
13 2008 Dr. M.S. Vishveshwara “An open label, muticenter phase 2 study to evaluate efficacy and safety of P276-00 in Indian subjects with recurrent, Metastatic or unresectable locally advanced squamous cell carcinoma of head and neck”. II P276-00/21/08 Nicholas Piramal Piramal Life Sciences BHIO Closed
14 2008 Dr. Ajai Kumar “Evaluation of safety and efficacy of dendritic cell vaccine derived from autogenic blood aspirates in patients with stage II and III squamous cell carcinoma of head and neck.” IIT BIO Closed
15 2008 Dr. Ajai Kumar “Evaluationof the best feasible tissue (FFPE or snapFrozen tissue) for the detection of MGMT methylation status in patients with Gliblastoma multiforme IIT BIO Closed
16 2008 Dr. Vineet Gupta “An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients. ”. II CT 4002 Medigene Pharmanet BIO Closed
17 2009 Dr. Niti Narang Multicentric Bioequivalence study comparing single dose of Capecitabine 500 mg tablets X 4 of Cipla Limited, (India) with single dose of Xeloda® 500 mg tablets X 4 (each containing 500 mg of Capecitabine) of Roche Ltd., U.K., in 72 patients with Colon, Colorectal or Breast Cancer under fed conditions. BA/BE PRC/CRD/33/08 Cipla Clintec BIO Closed
18 2009 Dr. Shekar Patil Efficacy and Safetyof TULY (Rasburicase) in Prevention and Treatment of Malignancy – associated Hyperuricemia – an Open Label, Multicentre study in India III VB037-2007 Virchow Virchow BIO Closed
19 2009 Dr. Shekar Patil Non Interventional Study of Indian Patients with Advanced Renal Cell Cancer receiving therapy with Sutent IV A6181181 Pfizer Pfizer BIO Closed
20 2009 Dr. Shekar Patil Retrospective Data Collection Study for Breast Cancer IIT Institution BIO Closed
21 2009 Dr. Bhawana Awasthy Study for assessment of Informed Consent Process IIT Institution BIO Closed
22 2010 Dr. Radheshyam Naik Retrospective Evaluation of Efficacy and Safety of Generic Chemotherapeutic Formulations of Fresenius Kabi Oncology(Gemcitabine, Docetaxel, Irinotecan, Oxaliplatin and Paclitaxel) versus Historical Data in the Treatment of Advanced Colorectal Carcinoma (CRC), Non-small cell Lung Cancer (NSCLC), Carcinoma Breast, Squamous Cell Carcinoma of Head and Neck (SCCHN), Pancreatic Carcinoma and Gastric Adenocarcinoma in clinical practice setting in India: Retrospective, Comparative, Multicenter, Cohort study IV HNL/ONCO/01/10 Fresenium kabi Oncology Hanul Medizin BIO Closed
23 2010 Dr. Ashish Kaushal a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-Care) III 20060359 (D-CARE) Amgen Amgen Medisurge Closed
24 2010 Dr. Shekar Patil A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer. II PPHM0902 Perigrene PRA International BIO Closed
25 2010 Dr. Radheshyam Naik Efficacy and safety of Long-term (6 Months) Innohep® Treatment versus Anticoagulation with a Vitamin K Antagonist (Warfarin) for the Treatment of Acute Venous Thromboembolism in Cancer Patients/ IN 0901 INT. III IN 0901 INT LEO Pharma PRA International BIO Closed out
26 2010 Dr. Radheshyam Naik Randomized, Comparative, Phase III Clinical Trial to Compare the Efficacy and Safety of Recombinant Human Pegylated Granulocyte Colony Stimulating Factor (Peg G-CSF) Versus Granulocyte Colony Stimulating Factor (G-CSF) In Subjects with Nonmyeloid Malignancies Receiving MyeloSuppressive Chemotherapy. III P3-Peg G-CSF-02 Wockhardt Wockhardt BIO Closed
27 2010 Dr. Shekar Patil A phase 3, randomized, Double-Blind Trial of Weekly Paclitaxel Plus AMG 386 or Placebo In Women with Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal or fallopian Tube Cancers III 20090508 Amgen NA BIO Closed
28 2010 Dr. Radheshyam Naik An open-label multicentre phase IV study of trastuzumab in combination with the standard chemotherapy (as per the routine clinical practice) as first line therapy in patients with HER2 positive metastatic gastric cancer IV ML25477 Roche Roche BIO Closed out
29 2010 Dr. Shekar Patil Establishment of registry for collating the epidemiology and treatment pattern data of Lymphoma in India IIT BIO Closed
30 2010 Dr. Shekar Patil A multicenter study of EGFR mutation analysis in non or ex-light smoker NSCLC Patients IIT BIO Closed
31 2010 Dr. Ajai Kumar A Prospective and Retrospective study to determine the Factors Affecting Disease Free Survival and Overall Survival in Patients with Gastric cancer Undergoing Curative Surgery IIT TS-04-2010 HCG Triesta BIO Closed
32 2010 Dr. Ajai Kumar A project involving the systematic archival of snap frozen and/or formalin fixed paraffin embedded tissues from patients of malignancy undergoing surgery for their disease.//// A project involving the systemic archival of biospecimens (tissue, blood, plasma, serum, DNA samples) from patients of malignancy undergoing surgery/ biopsy for their disease IIT BR-008-02 HCG Triesta BIO Closed
33 2010 Dr. Shekar Patil Open label, non controlled non randomized interventional pilot study to evaluate the response rate after induction therapy with Docetaxel and Cisplatin in unresectable locally advanced Squamous cell CA in head and Neck study IV DOCET_L_05090 Sanofi Aventis BIO Closed
34 2011 Dr. Shekar Patil Efficacy and safety of Paclitaxel nono-dispersion concentrate for injection (PICN) in subjects with metastatic breast cancer: A randomized, open label, active controlled, comparative, parallel group, and multi-centric study. BA/BE CLR_10_13 SunPharma Sun Pharma BIO Closed
35 2011 Dr. Shekar Patil A Randomised, open-label, Phase 2 Trial of Paclitaxel/ Carboplatin with or without Bavituximab inpatients with Previously Untreated locally Advanced or Metastatic Non- Squamous Non-Small-Cell Lung Cancer. II PPHM1001 Peregrine PRA International BIO Closed
36 2011 Dr. Raghunath SK An International, Multi-Center, Open Label, Randomized Study Assessing the Safety and Efficacy of a Monthly Dosing Regimen of Ozarelix versus Goserelin Depot (Zoladex®) in Men with Prostate Cancer II SPI-153-10-1 Spectrum International Oncorx BIO Closed
37 2011 Dr. Amit Verma Ex-vivo study on Cervical Tissue characterization using Photonic Tool. IIT Philips Triesta Referance Lab BIO Closed
38 2011 Dr. Ajai Kumar A Randomized, multicenter, phase III open label study of the efficacy and safety of Trastuzumab-Mcc-Dml vs Capecitabine + Lapatinib in patients with Her 2 Positive locally advanced or Metastatic Breast Cancer who have received prior Trastuzumab – based therapy III BO21977 Roche Roche BIO Closed out
39 2011 Dr. Radheshyam Naik Comparative PK, Efficacy, Safety and Immunogenicity evaluation of Bmab-200 versus Herceptin®, both in combination with Docetaxel in patients with Her2+ Metastatic Breast Cancer: A Double Blind, Randomised, Active control, Parallel assignment, Comparative Phase III, Clinical Trial III BM200-CT3-001-11 Biocon Clinigene BIO Closed
40 2011 Dr. Kumar Swamy Clinical Validation of PROWESS IMRealART software for Adaptive Radiation therapy (ART) IIT TS-03-2011 Siemens Nil BIO Closed
41 2011 Dr. Radheshyam Naik Development of preclinical screening platform for personalized breast cancer treatment in India IIT TS-04-2011 Mitra Biotech Nil BIO Closed
42 2011 Dr. Aditi Bhat A Prospective Study to determine the Co-relation between Altered Biomarkers and poor response to Neoadjuvant Chemo radiation in Rectal Cancer IIT TS-02-2011 HCG HCG BIO Closed
43 2011 Dr. Shekar Patil A Randomized, Double-Blind, Multicenter Phase 3 Study of Irinotecan, Folinic Acid, and 5-Fluorouracil (FOLFIRI) Plus Ramucirumab or Placebo in Patients With Metastatic Colorectal Carcinoma Progressive During or Following First-Line Combination Therapy With Bevacizumab, Oxaliplatiun, and a Fluoropyrimidine III I4T-MC-JVBB© (also known as IMCL CP12-0902) Eli Lily Eli Lilly BIO Closed out
44 2011 Dr. Radheshyam Naik Collection of Serum Samples from Patients with Metastatic breast Cancer for Development and Validation of Bio-analytical methods for Bmab-200 III CL-BM200-001 Biocon Clinigene BIO Closed
45 2011 Dr. Sameer Khatri An open label, phase II trial of BIBW 2992 (afatinib) in patients with metastatic HER2-overexpressing breast cancer failing HER2-targeted treatment in the neoadjuvant and/or adjuvant treatment setting II 1200.98 (BI) Manipal Manipal BIO Closed
46 2011 Dr. Radheshyam Naik A Randomised Open-label Phase IIa Study to Assess the Efficacy and Safety of AZD4547 Monotherapy versus Paclitaxel in Patients with Advanced Gastric or Gastro-Oesophageal Junction Cancer with FGFR2 Polysomy or Gene Amplification (Shine Study) IIA D2610C00004 Astrazeneca Astrazeneca BIO Closed
47 2012 Dr. Shilpa Prabhu Desai Digital Pathology Pilot study IIT Philips BIO Closed
48 2012 Dr. Amit Verma Phase I/II Trial using Solid Lipid based Curcumin Nano-particles for early stage Bladder Cancer. II NA ICMR NA BIO Closed
49 2012 Dr. Shekar Patil A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Docetaxel Injection Concentrate for Nano-dispersion (DICN) in Subjects With Unresectable Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) IB CLR_11_10 Sun Pharma Sun Pharma BIO Closed
50 2012 Dr. Sridhar P S An International randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma. (The “ACT IV” Study) IV CDX110-04 Celldex Novatech BIO Closed
51 2012 Dr. Shekar Patil Clinical and epidemiological Study of EGFR Mutation and EML4-ALK Fusion Gene Among Indian Patients with Adenocarcinoma Lung. IIT NA Pfizer Pfizer BIO Closed
52 2012 Dr. Shekar Patil A Phase III Prospective, Two-Cohort, Non-Randomized, Multi-Centre, Multinational, Open Label Study To Assess The Safety Of Assisted And Self Administered Subcutaneous Trastuzumab As Adjuvant Therapy In Patients With Operable Her2 Positive Early Breast Cancer [SafeHer Study] III MO28048 Roche Roche BIO Closed
53 2012 Dr. Shekar Patil A Multicenter open-label randomized study of BCD-020(rituximab, CJSC BIOCAD, Russia) efficacy and safety in comparison with MabThera® (F. Hoffmann-La Roche Ltd., Switzerland) in monotherapy of CD20-positive indolent non-Hodgkin lymphoma” III BIORIX CJSC BIOCAD SMO India BIO Closed
54 2012 Dr. Radheshyam Naik An Exploratory, Obervational study to evaluate the Efficacy and Safety of Daptomycin in treating Neutropenic patients with fever due to known or suspected Gram Positive infections in adult Hemato-Oncology Patients. IV CCBC134AIN03T Novartis BIO Closed
55 2012 Dr. KNC Murthy Pharmacokinetics and Early Phase-II Clinical Study on anti inflammatory benefits of Dietary Triterpenoids IIT ICMR NA BIO Closed
56 2012 Dr. Raghunath SK A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA. II B1131004 Pfizer Parexel BIO Closed
57 2012 Dr. Raghavendra Rao Prevalence and Perceptions of CAM in Indian Cancer Patients A Multi Institutional Cross Sectional Survey. IIT Academic Study ICMR Triesta BIO Closed
58 2012 Dr. Radheshyam Naik A Phase III, Randomized, Double-Blind Active Comparator-Controlled Parallel-Group study Conducted Under In-House Blinding Conditions to examine the Efficacy and Safety of a Single 150mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of chemotherapy Induced Nausea and Vomiting (CINV) Associated with Moderately Emetogenic Chemotherapy III MK 0517-031 Merck Siro BIO Closed out
59 2012 Dr. Radheshyam Naik A Randomised, double-blind, double-dummy, parallel-group multicenter study to demonstrate improvement in symptoms of constipation and non inferiority in analgesic efficacy in subjects with non-malignant or malignant pain that requires around-the-clock opioid therapy taking 50/25 – 80/40 mg twice daily as Oxycodone/Naloxone prolonged release (OXN PR) tablets compared to subjects taking 50 – 80 mg twice daily Oxycodone prolonged release (Oxy PR) tablets alone. III OXN3506 Mundipharma INC BIO Closed
60 2012 Dr. Sudhakar Compare the lesion detection accuracy of Contrast Enhanced Spectral Mammography with Standard Mammography and Ultrasound in Women with Dense Breast or suspicious lesion. IIT TS-02-2012 HCG/GE Triesta BIO Closed
61 2012 Dr. K G Kallur Benefits of PET VCAR2 in comparing baseline and follow-up PET/CT studies IIT TS-03-2012 HCG/GE Triesta BIO Closed
62 2012 Dr. Raghavendra Rao Patterns of Care and Survival Studies IIT HCG/national Program Triesta BIO Closed
63 2012 Dr. Radheshyam Naik Retrospective Immunohistochemistry assessment of c-MET over expression in Head and Neck cancer in the Indian Population. IIT TS-04-2012 GE Healthcare Triesta BIO Closed
64 2012 Dr. Nalini Rao Value of PET in staging and monitoring treatment response in breast cancer: A Retrospective analysis IIT GE Healthcare Triesta BIO Closed
65 2012 Dr Shilpa Prabhu Desai Magna Tech Technology IIT Biocon BIO Closed
66 2012 Dr. Shekar Patil A Phase I/II First in Human, Open Label, Multi-centre, Dose Escalation, Dose Finding, Safety and Tolerability Study of BVX20 administered intravenously in patients with Relapsed/Refractory CD20+ B cell Non Hodgkin’s Lymphoma I BVX 20-CT-001-10 Biocon Clinigene BIO Closed out
67 2012 Dr. Radheshyam Naik A multicenter, double-blind, randomized, parallel-group, phase III study to compare the efficacy and safety of Hercules versus Herceptin® in patients with HER2+ metastatic breast cancer III MYL-Her3001 Mylan INC BIO Closed
68 2013 Dr. Shekar Patil A Phase III, open-label, multicenter, randomized trial to establish safety and efficacy of an EGF cancer vaccine in inoperable, late stage (IIIb/IV) NSCLC patients eligible to receive standard treatment and supportive care. III BV-NSCLC-001 Bioven IndiPharma BIO Closed out
69 2013 Dr Pramod S Chinder Efficacy of Autologous Mesenchymal stem cells transplantation and its correlation with tractography in patients with spinal cord diseases. IIT TS-01-2013 HCG HCG-BIO HCG-BIO Closed
70 2013 Dr. Radheshyam Naik International multicenter randomized double blind phase III trial comparing safety and efficacy of BCD-021 (CJSC BIOCAD, Russia) and paclitaxel + carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and paclitaxel + carboplatin in inoperable or advanced non-squamous non-small-cell lung cancer patients. III BCD-021-02 BIOCAD BIOCAD HCG-BIO Closed
71 2013 Dr. Shekar Patil A Phase III, multicenter, open-label, randomized trial comparing the efficacy of GA101 (RO5072759) in combination with chop (G-CHOP) versus Rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) III BO21005 Roche Roche HCG-BIO Closed
72 2013 Dr. Gopinath K.S. An observational study to determine Thromboembolism prophylaxis in oncology patients who are undergoing abdominal or pelvic surgery Observational Study DIREGL06283 Sanofi Aventis Sanofi Aventis HCG-BIO Closed
73 2013 Dr. Radheshyam Naik Randomized phase II study of BEZ235 or everolimus in advanced pancreatic neuroendocrine tumors. II CBEZ235Z2401 Novartis Novartis HCG-BIO Closed
74 2013 Dr Padma Kamineni Correlation of Oncoprinting with K-RAS testing in Colorectal Cancer Retrospective study NA HCG HCG-BIO HCG-BIO Closed
75 2013 Dr. Radheshyam Naik A Multicenter, Single Arm Study Of Trastuzumab Emtansine (T-Dm1) In Her2-Positive Locally Advanced Or Metastatic Breast Cancer Patients Who Have Received Prior Anti-Her2 And Chemotherapy-Based Treatment III MO28231 Roche Roche HCG-BIO Closed
76 2013 Dr.Govind Babu A phase III multicenter, randomized study of oral LDK378 versus standard chemotherapy in previously untreated adult patients with ALK rearranged (ALK-positive), stage IIIB or IV, non-Squamous non-small cell lung cancer III CLDK378A2301 Novartis Novartis HCG-CCO Closed
77 2013 Dr. Radheshyam Naik Post-marketing (Phase IV) Trial to monitor the adverse events of Fosaprepitant (EMEND® IV) in Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Moderate or High Emetogenic Chemotherapy in Usual Practice in India IV MK0517-035-01 Merck GVK Bio HCG-BIO HCG-CCO Closed
78 2013 Dr Rani Bhat Comparative study to determine whether the Zetiq CellDetect® technology is as effective as the currently recommended approach Pap smear test for screening of cervical cancer IIT TS-0X-2013 HCG HCG-BIO HCG-BIO Closed
79 2013 Dr. Shekar Patil Outcomes of HCC patients treated with TACE followed or not followed by sorafenib and the influence of timing to initiate sorafenib. IV OPTIMIS Bayer Healthcare AG Bayer Healthcare AG HCG-BIO Closed
80 2014 Dr. Raghunath SK “A Multicenter, randomized, open label, two treatment, two period, two sequence, multiple-dose, cross-over, bioequivalence study of Everolimus 10 mg tablet once daily manufactured by Par Pharmaceutical, Inc. 1 Ram Ridge Road, Spring Valley, NY 10977,USA with Afinitor (Everolimus) 10 mg tablet manufactured by: Novartis Pharma Stein AG Stein, Switzerland and Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 in Advanced Renal Cell Carcinoma patients under fasting condition”. BA/BE 13-VIN-537 Par Pharmaceutical Veeda CRO HCG-BIO Completed
81 2014 Dr. Raghunath SK “Pharmacodynamics efficacy and safety of Leuprolide depot 7.5 mg (SPIL) in subjects with Prostate Adenocarcinoma”. IV CLR-13-14 Sun Pharma HCG-BIO Closed
82 2014 Dr. Govinda Babu “Aflibercept 4mg/kg intravenously every 2 weeks, in combination with irinotecan-fluoropyrimidine-based chemotherapy, in patients with metastatic Colorectal Cancer previously treated with an oxaliplatin-containing regimen”. III NA Sanofi HCG-SMH & HCG CCO Closed
83 2014 Dr. K G Kallur “Use of Radioisotopes for diagnositc and therapeutic purposes under proposal of Radioisotopes for diagnosis and therapy” IIT HCG BIO HCG BIO Closed
84 2014 Dr. Shashidhara HP A Phase III Randomised, Double-Blind, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokineticsand Immunogenecity between SB3(proposed transtuzumab biosimilar) and Herceptin in women with Newly Diagnosed HER2 Positive Early or Locally Advanced Breast Cancer in Neoadjuvent setting III SB3-G31-BC SIRO BIO Closed
85 2014 Dr. Radheshyam Naik Incidence of invasive fungal infection in patients undergoing chemotherapy for acute myeloid leukemia – impact of antifungal prophylaxis. A prospective, multicenter, observational study in India Observational Study Merck HCG Bio Closed
86 2014 Dr. Sridhar P S Interim PET/CT as a prognostic factor for Head/Neck Cancer Retrospective study Closed
87 2014 Dr. Basant Mahadevappa To evaluate recurrence Retrospective study Closed
88 2014 Dr. K G Kallur Requested for approval for PET images for feedback on Q –Clear processing software IIT WIPRO GE Health care Closed
89 2014 Dr. Vineet Gupta Breast Cancer Registry to collate data on epidermiology and treatment patterns and outcomes of breast cancer in India III Roche HCG-SMH Closed
90 2014 Dr. K G Kallur Benefits of PET VCAR2 in Comparing pre-treatment and Post treatment PETCT studies in Lymphoma Patients versus interpretation IIT TS-03-2012 GE health care HCG BIO Closed
91 2014 Dr.Govind Babu A Double Blind, Randomized, Active controlled, Parallel design, Comparitive PK, efficacy, Safety, and immunogenicity study of Bmab-100 and Avastin®, both in combimation with XELOX chemotherapy in patients with Metastatic Colorectal cancer. III BM100-CC-03-I-01 Clinigene HCG -CCO Closed
92 2014 Dr.Govind Babu A open label, Multi-centre, Expanded Treatment Protocol (ETP) of oral LDK378 in adult patients with non-small cell lung cancer (NSCLC) characterized by ALK positivity study number CLDK 378A2402 III CLDK378A2402 Novartis Novartis HCG CCO Closed
93 2014 Dr. Vishakha Mangale, Comparative study and Identification of specific Hemato – Lymphoid abnormalities in peripheral blood or bone marrow or by multicolor flow cytometry Retrospective study Bangalore Development Centre, Beckman Coulter Inc HCG BIO Closed
94 2015 Dr. Shashidhara HP A Multicentre, Open label, Balanced, Randomized, Two-treatment, Two-period, Single dose, Crossover, Bioequivalence study of Bortezomib for Injection 3.5 mg/vial of Dr. Reddy’s Laboratories Limited, India and VELCADE® (bortezomib) for Injection 3.5 mg/vial (Distributed by: Millennium Pharmaceuticals, Inc., 40 Landsdowne Street, Cambridge, MA 02139) in previously untreated Multiple Myeloma and/or Relapsed/Refractory Multiple Myeloma patients. III 14-VIN-648 Dr. Reddy Veeda HCG BIO Closed
95 2015 Dr. Shekar Patil A Prospective, Comparative, Open Label, Randomized, Multicentric, Phase III study to compare the safety and efficacy of Bevacizumab of Intas Pharmaceuticals Limited against Avastin™ in Patients with Unresectable or Metastatic Non- Squamous Non-Small Cell Lung Cancer III 476-13 Lambda HCG BIO Closed
96 2015 Dr.Govind Babu A Phase III randomized, double-blind, placebo controlled study of LEE011 or placebo in combination with tamoxifenand goserelin or a non-steroidal aromatase inhibitor (NSAI) and goserelin for the treatment of premenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer III CLEE011E2301 Novartis HCG BIO Closed
97 2015 Dr. Radheshyam Naik Reditux™ Registry to Compare Effectiveness, Safety and Resource Utilization of Reditux™ vs. the Reference Medicinal Product to Treat Diffuse Large B-Cell Lymphoma and Chronic Lymphocytic Leukemia in Routine Clinical Practice Observational Study RI-02-003 Dr. Reddy Pharmex HCG BIO Closed
98 2015 Dr. Raghunath SK A Prospective, multicenter, post-marketing surveillance to assess safety of Zytiga® (Abiraterone Acetate Tablets 250 mg) in Indian patients with metastatic, castration-resistant prostate cancer as per locally approved prescribing information IV 212082PCR4021 Janssen & Janssen HCG BIO Closed
99 2015 Dr.Govind Babu A Phase Ib dose escalation followed by a phase II singlearmstudy of the combination of LEE011 with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2- negative, advanced breast cancer IB CLEE011A2115C Novartis HCG – BIO HCG – CCO Closed
100 2015 Dr. Radheshyam Naik A Randomized, Double-Blind, Multi-Centre, Parallel Group Study Comparing Two Humanized Monoclonal Antibodies that Target HER2 Receptors in combination with Weekly Paclitaxel Administered as First-Line Treatment in Patients with HER2-Positive Metastatic Breast Cancer III TZ-01-002 Dr. Reddy Manipal Acunova HCG – BIO Closed
101 2015 Dr. Viveka B K An Open Label, Single Arm Phase III Study of Nintedanib plus Best Supportive Care (BSC) in Patients with Colorectal Cancer Refractory to Standard Therapies III 1199.235 Boehringer Ingelheim Pharmaceuticals, Inc Boehringer Ingelheim Pharmaceuticals, Inc HCG – BIO Closed
102 2015 Dr. Radheshyam Naik A Multicenter, Open-Label, Single-Arm, Phase IV Study Of Trastuzumab emtansine in Indian Patients with HER2 – Positive Unresectable Locally Advanced Or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and Taxane IV ML29662 Roche Roche HCG – BIO Closed
103 2015 Dr. Shekar Patil A Phase III Randomized, Open – Label, Multi-Center, Global Study of MED14736 in combination with Tremelimumab Therapy Versus Standard of Care Platinum-Based Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) (NEPTUNE) III D419AC00003 Astrazeneca Astrazeneca HCG – BIO Closed
104 2015 Dr. Raghunath SK A Randomized, multicenter, open label, two- treatment, two period, two sequence, multiple dose, crossover , steady state bioequivalence study of Everolimus tablets, 10mg of Biocon limited, India vs Afinitor® (Everolimus) tablets, 10 mg of Novartis Pharmaceuticals Corporation, USA in advanced renal cell carcinoma (RCC) patients. BA/BE 15-VIN-155 Biocon Veeda HCG – BIO Closed
105 2015 Dr. Viveka B K “A randomized double blind study in two parts Part A – Comparing two humanized monoclonal antibodies that target VEGF in combination with mFolfox 6 in patients with non-resectable metastatic colorectal cancer (mCRC) Part B – Comparing two humanized monoclonal antibodies that VEGF in combination with pemetrexed and carboplatin in recurrent or advanced non squamous non-small cell lung cancer (NSCLC)” III BZ-01-002 Dr. Reddy Diagnosearch HCG – BIO Closed
106 2016 Dr. Viveka B K A study of Palbociclib in combination with Letrozole as treatment of post-menopausal women with hormone receptor-positive, Her 2 Negative advanced breast cancer for whom Letrozole therapy is deemed III A5481037 Pfizer Parexel HCG – BIO Closed
107 2016 Dr. Raghunath SK An Open-label, Single-Arm, Multicentre, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed with Advanced Hormone-dependent Prostate Cancer IV 000201 / Ferring Maxneeman HCG – BIO Closed
108 2016 Dr. Shekar Patil RIFTOS MKI – Radioactive Iodine reFractory asymptomatic patients in differentiated Thyroid cancer – an Observational Study to assess the use of MultiKinase Inhibitors Observational Study 17852 Bayer Healthcare AG Bayer Healthcare AG HCG – BIO Closed
109 2016 Dr. Radheshyam Naik A Prospective, Placebo Controlled Study on Caripill Tablet in Management of Chemotherapy induced Thrombocytopenia in solid tumors IIT TS-01-2016 Micro Labs Limited Triesta HCG – BIO Closed
110 2016 Dr. Kumar Swamy Effects of therapies for comorbidities on cancer presentation IIT HCG HCG – BIO Closed
111 2016 Dr. Radheshyam Naik A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate Fro Nano-Dispersion (PICN) And Abraxane® In Subjects With Locally Recurrent Or Metastatic Breast Cancer. BA/BE CLR_15_12 Sun Pharma Sun Pharma HCG – BIO Closed
112 2016 Dr. Yogesh Shivkumar Using Circulating Tumour DNA (CtDNA) as a liquid biopsy – A validation study IIT HCG HCG – BIO Closed
113 2016 Dr. Radheshyam Naik CORRELATE – Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings. Observational Study 16821 Bayer Healthcare AG Bayer Healthcare AG HCG – BIO Closed
114 2016 Dr.Govind Babu A phase Ib/II, open-label, multicenter trial with oral cMET inhibitor INC280 alone and in combination with erlotinib versus platinum/permetrexed in adult patients with EGFR mutated, cMET amplified, locally advanced/metastatic non-cell lung cancer (NSCLC) with acquired resistance to prior EGFR tyrosine kinase inhibitor (EGFR TKI). II CINC280B2201 Biocad HCG – BIO Closed
115 2016 Dr. Shashidhara HP A multi-centric, prospective observational registry of Everolimus across 2 indications and doses. IIT HCG – BIO Closed
116 2016 Dr. Radheshyam Naik A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study Of Paclitaxel Injection Concentrate For Nano-Dispersion (PICN) And Abraxane® In Subjects With Locally Recurrent Or Metastatic Breast Cancer BA/BE CLR_16_12 Sun Pharma HCG – BIO Closed
117 2016 Dr. Radheshyam Naik A Prospective, Multi Centre, Observational, Data Collection Registry Study To Monitor The Routine Clinical Use Of Mabtas (Rituximab 100 Mg / 500 Mg Concentrate For Solution For Infusion, Manufactured By Intas Pharmaceuticals Ltd) In Indian Patients. Observational Study 762-15 Intas Pharmaceuticals HCG – BIO Closed
118 2016 Dr. Radheshyam Naik A multicenter, Observational, Post Marketing Surveillance to Evaluate the Safety of Trastuzumab infusion (marketed as CANMAB of Biocon Limited, India/Hertraz TM of Mylan Pharmaceuticals Pvt. Ltd., India) administered as per the approved prescribing information in patients with HER2 overexpressing Metastatic Breast Cancer. Observational Study BIINTR001 Cliantha Research Ltd Cliantha Research Ltd HCG – BIO Closed
119 2016 Dr. Srinivasa B J A Phase III Randomized, Open-label, Multi-center, Global Study of MEDI4736 Alone or in Combination with Tremelimumab versus Standard of Care in the Treatment of First-line Recurrent or Metastatic Squamous Cell Head and Neck Cancer Patients III D419LC00001 Astra Zeneca Astrazeneca HCG – BIO Closed
120 2016 Dr.Govind Babu A Randomized, Double-Blinded, Placebo-Controlled, Phase 3 Study to Compare NSAI(Anastrozole or Letrozole) plus Abemaciclib, a CDK4 and CDK6 Inhibitor, or plus Placebo and compare Fulvestrant plus Abemaciclib or plus Placebo in Postmenopausal Womwn with Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Brest Cancer. III 13Y-CR-JPBQ Eil Lilly HCG – BIO Closed
121 2016 Dr. Radheshyam Naik A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study Of Paclitaxel Injection Concentrate For Nano-Dispersion (PICN) And Abraxane® In Subjects With Locally Recurrent Or Metastatic Breast Cancer BA/BE CLR_16_13 Sun Pharma Sun Pharma HCG – BIO Closed
122 2016 Dr. Satheesh C T A Phase 3, Randomized, Double-blind study of PF-05280586 Versus Rituximab for the First-line Treatment of Patients with CD20-Positive, Low Tumor Burden, Follicular Lymphoma III B3281006 Pfizer HCG Closed
123 2016 Dr. Shekar Patil An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy IV 1199.272 Boehringer-Ingelheim HCG Closed
124 2016 Dr. Shekar Patil A real-world, open-label, multi-center, prospective, non-interventional (observational) study to evaluate the effectiveness and tolerability of ceritinib in Indian patients with ALK positive metastatic non-small cell lung cancer who have progressed or are intolerant to crizotinib IV CLDK378AIN01 Novartis healthcare HCG Closed
125 2016 Dr.Govind Babu A multi-center, randomized open label study to assess the systemic exposure, efficacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC) III CLDK378A2112 Novartis curie – a unit of HealthCare Global Enterprises Limited Closed
126 2016 Dr. Shekar Patil A Multicenter, Observational, Post Marketing Surveillance to evaluate the Safety of Trastuzumab intravenous infusion (marketed as CANMAb of Biocon Limited, India/HertrazTM of Mylan Pharmaceuticals Pvt. Ltd., India) administered as per the approved prescribing information in patients with HER2 overexpressing Metastatic Breast Cancer III BIINTR001 Novartis HCG Closed
127 2016 Dr. Renu Ethirajan Protocol for clinical validation of ShonitTM at HCG, Bangalore Observational Study sigtuple HCG Closed
128 2016 Dr. Radheshyam Naik A prospective, multicenter, double-randomized, double-blind, 2-parallel groups, phase 3 study to compare as first line therapy efficacy and safety of masitinib in combination with gemcitabine, to gemcitabine in combination with placebo, followed as second line treatment by masitinib in combination with Folfiri 3 versus placebo in combination with Folfiri 3 in the treatment of patients with non resectable locally advanced or metastatic pancreatic cancer III AB12005 AB Science HCG Closed
129 2016 Dr. Sampathkumar MN A Randomized, Double-blind, Multicentric, Parallel-group Study Comparing Efficacy, Safety and Immunogenicity of CBT124, a Candidate Biosimilar Bevacizumab in Combination with Carboplatin and Paclitaxel with EU-sourced Avastin® in Combination with Carboplatin and Paclitaxel in First-line Treatment for Subjects with Stage IV (Unresectable Recurrent Disease or Metastatic) Non-squamous Non-Small Cell Lung Cancer (NSCLC) III CBT124/CT/002 cipla HCG Closed
130 2016 Dr. Girish V Badarke A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy and Safety of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma III AGB002 Quintiles HCG Closed
131 2016 Dr. Radheshyam Naik A multicenter, open label, randomized, two treatment, two period, two way crossover, single dose, bioequivalence study of paclitaxel protein-bound particles for injectable suspension (albumin-bound) 100 mg/vial by Cipla Ltd., India with ABRAXANE® for injectable suspension (Paclitaxel protein-bound particles for injectable suspension( (albumin-bound) 100 mg/vial by Celgene Corporation, USA in breast cancer patients after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. BA/BE CRD-09 Siro ClinPharma HCG Closed
132 2016 Dr. K G Kallur Radioimmunotherapy with alpha particles Actinium 225 and Bismuth213  in HCG specialty center Bangalore IIT HCG – BIO Closed
133 2016 Dr. Vijay Agarwal A Randomized, Double-blind, Placebo-controlled, cross-over pilot study with Resveratrol in patients with advanced cancers undergoing non biological second line chemotherapy. IIT Epigenres Pvt Limited HCG – BIO Closed
134 2016 Dr. Shashidhara HP A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetic Characteristics of Intravenous Infusion of Trastuzumab (Hetero) and Reference Medicinal Product (HERCEPTIN® – Trastuzumab, Genentech, Inc.) in combination with standard chemotherapy in Patients of HER2-positive Metastatic breast cancer (TRUMAB Study). III HCR/III/TRUMAB/05/2016 Hetero Drugs Limited HCG – BIO Closed
135 2017 Dr. Shekar Patil Safety Study of Nivolumab for Selected Advanced Malignancies in India. IV CA209-887 ICON HCG – BIO Closed
136 2017 Dr. Radheshyam Naik PAzopanib Real-world Assessment of Clinical effectiveness and safety in patients wHo have Undergone Treatment in different sEttings in advanced renal cell carcinoma; a prospective, non-interventional, observational study. IV CPZP034AIC04 (PARACHUTE) Novartis Healthcare Pvt Ltd HCG – BIO Closed
137 2017 Dr. Shekar Patil PAzopanib Real-world Assessment of Clinical effectiveness and safety in patients wHo have Undergone Treatment in different sEttings in advanced renal cell carcinoma; a prospective, non-interventional, observational study. IV CPZP034AIC04 (PARACHUTE) Novartis Healthcare Pvt Ltd HCG – BIO Closed
138 2017 Dr. Radheshyam Naik A two arm, randomized, multicentric, open label, efficacy and safety study of Docetaxel Lipid Suspension (DLS) for Injection of Intas Pharmaceuticals Limited, India in Non-Small Cell Lung Cancer patients. III 0907-16 Intas Lambda Therapeutic Research Ltd HCG – BIO Closed
139 2017 Dr. Radheshyam Naik A multicenter, open label, randomized, two-treatment, two-period, two-sequence, single dose, cross-over bioequivalence study of Doxorubicin Hydrochloride (Pegylated liposomal) concentrate for solution for infusion 20 mg/10mL (2 mg/ml) of Dr. Reddy’s Laboratories Ltd, India, with that of Caelyx® 2mg/mL [Doxorubicin Hydrochloride (Pegylated Liposomal) concentrate for solution for infusion (20 mg/10mL)] of Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium in advanced ovarian cancer or metastatic breast cancer subjects under fed condition. BA/BE 0076-17 Dr. Reddy’s Laboratories Lambda Therapeutic Research Ltd HCG – BIO Closed
140 2017 Dr. Radheshyam Naik An open label, balanced, randomized, two-treatment, two-sequence, two-period, crossover, multi center, multiple dose steady state bioequivalence study of Everolimus tablets 10 mg of Dr. Reddy’s Laboratories Limited, India comparing with that of AFINITOR® (everolimus) tablets 10 mg, Manufactured by Novartis Pharma Stein AG Stein, Switzerland in subjects of advanced renal cell carcinoma (RCC) who are already receiving Everolimus at a stable dose of 10 mg once a day as their individual therapy III 17-VIN-0028 Dr. Reddy’s Laboratories VeedaCR HCG Closed
141 2017 Dr Suraj H.P NIS (Sodium Iodide Symporter) gene: Analysis of expression in Thyroid cancer patients – A pilot study IIT HCG Closed
142 2017 Dr. Richitha V. Pandit Actionable Genomic Mutations in Head and Neck Cancers: a pilot study IIT HCG Closed
143 2017 Dr. Radheshyam Naik Prospective Observational Study to Evaluate the Effectiveness of Syndrome Evaluation System in Diagnosis and Management of Infections in Bone Marrow Transplant and Malignant or Non Malignant Hematological Conditions IIT HCG Closed
144 2017 Dr. Vishal Rao Does palmistry/ vedic astrology have a role in time of the diagnosis of cancer patients – a cross sectional study IIT HCG Closed
145 2017 Dr. Girish V Badarke Comparative study and Identification of specific Hemato ‐ Lymphoid abnormalities and rare events in peripheral blood or bone marrow by multicolor flow cytometry Observational Study Beckman Coulter HCG Closed
146 2017 Dr. Gopinath K.S. CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS-1): A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscript™ in Routine Clinical Practice IIT Mitra biotech Catalyst Clinical Services HCG Closed
147 2017 Dr. Suraj HP Evaluation of post-operative outcome of surgically treated patients with spine metastasis IIT HCG Closed
148 2017 Dr. Suraj HP Outcome of Bone Allograft reconstruction following Musculoskeletal tumour resections IIT HCG Closed
149 2017 Dr. Shekar Patil An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of ribociclib (LEE011) in combination with letrozole for the treatment of men and pre/postmenopausal women with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease – COMPLEEMENT-1 IIIB CLEE011A2404 Novartis Novartis HCG Closed
150 2017 Dr. Sudhakar Multicentric Study to evaluate the effectiveness of Thermalytix© (automated thermographic screening algorithms developed by NIRAMAI) as compared to standard screening modalities in subjects who show possible symptoms of suspected breast cancer. Observational Study NI-THERMA-01 NIRAMAI NIRAMAI HCG Closed
151 2017 Dr. Satheesh C T International multicenter randomized double-blind phase III trial comparing safety and efficacy of BCD-021 (CJS BIOCAD, Russia) and paclitaxel + carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and paclitaxel + carboplatin in inoperable or advanced non-squamous non-small-cell lung cancer patients. III BCD-021-02 Biocad Biocad HCG Closed
152 2017 Dr. Vishal Rao Multi-centric Study for Screening and detection of oral potentially malignant disorders (OPMD) non-invasively by fluorescence and diffuse reflectance imaging with OralScan camera, and development of an algorithm for tissue discrimination. IIT Sascan Meditech HCG Closed
153 2017 Dr. Srinivasa B J A Two-Part, Open-Label, Randomized, Phase II/III Study of Dinutuximab and Irinotecan versus Irinotecan for Second Line Treatment of Subjects with Relapsed or Refractory Small Cell Lung Cancer. II/III DIV-SCLC-301 United Therapeutics Corporation Precision Oncology HCG Closed
154 2017 Dr. Radheshyam Naik A Phase 2, Open-Label Randomized Trial Evaluating the Efficacy and Safety of Two Dosages of Once Daily Oral CA-170 in Patients with Selected Relapsed Advanced Tumors (ASIAD) II CA-170-201 Aurigene Discovery Technologies Ltd. Aurigene Discovery Technologies Ltd. HCG Closed
155 2017 Dr. Shekar Patil A Phase II/III Pivotal, Open-label, Randomized, 3 Arm Study to Assess the Efficacy of LNP3794 Monotherapy or in Combination with Docetaxel, Compared with Docetaxel Alone, in Patients with RAS Mutation Positive Locally Advanced and Metastatic Non-Small Cell Lung Cancer. II/III LRP/LNP3794/2016/006 Lupin Lupin HCG Closed
156 2017 Dr. Srinivasa B J Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. Observational Study RET-BIO-NIM-001 ClinSync Clinical Research Pvt Ltd. ClinSync Clinical Research Pvt Ltd. HCG Closed
157 2017 Dr. Shekar Patil Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. Observational Study RET-BIO-NIM-001 ClinSync Clinical Research Pvt Ltd. ClinSync Clinical Research Pvt Ltd. HCG Closed
158 2017 Dr. Radheshyam Naik Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. Observational Study RET-BIO-NIM-001 ClinSync Clinical Research Pvt Ltd. ClinSync Clinical Research Pvt Ltd. HCG Closed
159 2017 Dr. P.S. Sridhar Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. Observational Study RET-BIO-NIM-001 ClinSync Clinical Research Pvt Ltd. ClinSync Clinical Research Pvt Ltd. HCG Closed
160 2017 Dr. Satheesh C T Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. Observational Study RET-BIO-NIM-001 ClinSync Clinical Research Pvt Ltd. ClinSync Clinical Research Pvt Ltd. HCG Closed
161 2017 Dr. Shashidhara HP Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in cancer patients. Observational Study RET-BIO-NIM-001 ClinSync Clinical Research Pvt Ltd. ClinSync Clinical Research Pvt Ltd. HCG Closed
162 2017 Dr. Satheesh C T A randomised, controlled, comparative, open-label, multicenter study on the safety and efficacy of PEG Neutrogen and Neulastim in prevention of chemotherapy-induced neutropenia Observational Study VB066P/2017-CT4 HCG KR Closed
163 2017 Dr. Vijay Agarwal A randomised, controlled, comparative, open-label, multicenter study on the safety and efficacy of Neutrogen and Neulastim in prevention of chemotherapy-induced neutropenia Observational Study VB066/2017-CT3 HCG KR Closed
164 2017 Dr. Shashidhara HP A MULTICENTRE, OPEN LABEL, BALANCED, RANDOMIZED, TWO-TREATMENT, TWO-PERIOD, SINGLE DOSE, CROSSOVER, BIOEQUIVALENCE STUDY OF BORTEZOMIB FOR INJECTION 3.5 MG/VIAL OF DR. REDDY’S LABORATORIES LIMITED, INDIA AND VELCADE® (BORTEZOMIB) FOR INJECTION 3.5 MG/VIAL (DISTRIBUTED AND MARKETED BY: MILLENNIUM PHARMACEUTICALS, INC., 40 LANDSDOWNE STREET, CAMBRIDGE, MA 02139) IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA AND/OR RELAPSED MULTIPLE MYELOMA PATIENTS III 17-VIN-0772 HCG Closed
165 2018 Dr. Satheesh C T A PHASE IV MULTI-CENTRIC POST-MARKETING STUDY EVALUATING THE SAFETY, IMMUNOGENICITY AND EFFICACY OF THE MARKETED FORMULATION OF HETERO – RITUXIMAB IV HCR/IV/Ritux/01/2017 Hetero Drugs Limited HCG KR Closed
166 2018 Dr. Satheesh C T “A PHASE IV POST-MARKETING STUDY EVALUATING THE SAFETY, IMMUNOGENICITY AND EFFICACY OF THE MARKETED FORMULATION OF HETERO – BEVACIZUMAB IN SOLID MALIGNANCIES IV HCR/IV/Bevaci/01/2017 Hetero Drugs Limited HCG KR Closed
167 2018 Dr. Vijay Agarwal a single arm, multicentric, open label, efficacy and safety study of docetaxel lipid suspension for injection of intas pharmaceuticals limited, india in metastatic gastric adenocarcinoma patients III 0328-17 Lambda HCG KR Closed
168 2018 Dr. Shekar Patil “A Non-interventional, multicentre study to assess prevalence of BRCA1 and BRCA2 mutation among ovarian, primary peritoneal and fallopian tube cancer patients in India (BRCA STUDY)”. Observational Study D0818R00001 HCG KR Closed
169 2018 Dr. Shekar Patil “A phase IV study to investigate the safety and efficacy of regorafenib in Indian patients with metastatic colorectal cancer (mCRC)”. Observational Study 19214 HCG KR Closed
170 2018 Dr. Jaganath Dixit “Prospective analysis of surplus fresh tumor tissue to understand the changes in tumor immune cells on exposure to immunomodulators using CANscript” Observational Study MBT-TB-038 HCG KR Closed
171 2018 Dr. Shekar Patil “Clinical Outcomes of CLL and MCL patients treated with Ibrutinib : An Observational retrospective medical chart review from India”. Observational Study 54179060LYM4007 HCG KR Closed
172 2018 Dr.Govind Babu A Phase III, multicenter, randomized, double blind, placebo-contorlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant theraphy in adult subjects with stages AJCC/UICC v.8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC) III CACZ885T2301 HCG DR Closed
173 2018 Dr. Shashidhara HP A multi-national randomized, multi-center, active controlled, open-label, Phase III study evaluating the efficacy of olmutinib versus platinum doublet chemotherapy in patients with T790M mutation positive locally advanced or metastatic non-smell cell lung cancer (NSCLC) whose disease progressed on one prior epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment. Observational Study HM-EMSI-301 HCG KR Closed
174 2018 Dr. Shekar Patil An observational, multicenter,prospective study to evaluate concordance of detecting EGFR mutation by circulating tumor free DNA versus tissue biopsy in NSCLC(CONCORDANCE) Observational Study D5161R00003 HCG KR Closed
175 2018 Dr. Shekar Patil A multicenter, Prospective, Epideriolgical study to Evaluate the Incidence of Selected Mutation in Non-Small Lung (NSCLC) patients in India IV InSPIRE Registry HCG Closed
176 2018 Dr. Raghunath SK “An exploratory pilot clinical validation study to correlate clinical outcome between physician decided therapy and its CANscriptTM response prediction in metastatic Catration Resistant Prostate Cancer (mCRPC)patients. Observational Study mCRPC study HCG KR Closed
177 2018 Dr. Shekar Patil A Global, multicentre, three arms, open-label randomized study to evaluate the efficacy and safety of Nanosomal Docetaxel Lipid Suspension Compared to Taxotere (Docetaxel Injection Concentrate) in triple – negative breast cancer patients with locally advanced or metastatic breast cancer after failure to prior chemotherapy. III 0063-17 HCG KR Closed
178 2018 Dr. Radheshyam Naik “An Indian Multicentric Open Label Prospective Post Marketing Surveillance Study of Bevacizumab in The Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer In Real-Life Clinical Practice.” IV ML28446 HCG KR Closed
179 2018 Dr. Radheshyam Naik “A retrospective study to assess the tumor response by correlating PET-CT with histopathology in Osteosarcoma patients at Tertiary Care Hospital.” IIT HCG KR Closed
180 2018 Dr. Vishal Rao “An observational, multicentre, prospective study to evaluate saliva based test in the early detection of Oral Cavity Squamous Cell Carcinoma (OCSCC).” Observational Study OCSCC HCG KR Closed
181 2018 Dr. Satheesh C T A randomized, double-blinded, parallel group, Phase III trial to compare the efficacy, safety and immunogenecity of TX-05 with herceptin in subjects with HER2 positive early breast cancer III TX-05-03 Tanvex HCG Closed
182 2018 Dr. Satheesh C T A doouble-blinded extension study to provide adjuvant treatment with single agent herceptin® or TX-05 and assessess continued safetty and immunogenecity in subjects with HER2 positive early breast cancer following neo-adjuvant treatment and surgical resection in protocol TX-05-03 III TX-05-04 Tanvex HCG KR Closed
183 2018 Dr. Radheshyam Naik A multicenter, observational, registry to study the safety and efficacy bio similar trastuzumab intravenous infusion in patients with early breast cancer. Observational Study BM 200-EBC-04-1-2 HCG KR Closed
184 2018 Dr. Radheshyam Naik An open-label, multicenter, randomized, two treatment, three period, three sequence, reference replicate crossover, single dose, bioequivalence study of test product of Irinotecan Liposome Injection, 43 mg/vial (manufactured by: CSPC Ouyi Pharmaceutical Co., Ltd. Shijiazhuang Hebei China, for Actavis Inc.) with reference product ONIVYDE™ (Irinotecan Liposome Injection), 43 mg/ vial (manufactured for: Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ USA) in Combination with Fluorouracil and Leucovorin in Patients with Metastatic Adenocarcinoma of the Pancreas after Disease Progression Following Gemcitabine-based Therapy. BA/BE CT/IRI/1603 HCG KR Closed
185 2018 Dr. Radheshyam Naik “A Multicenter Registry Examining The Clinical Utility Of Canscript In Routine Clinical Practice.” Observational Study MIT-201702 HCG KR Closed
186 2018 Dr. Shekar Patil KINDLE “A multi-country, multi-centre, observational, retrospective study to reveal the patient characteristics, disease burden, treatment patterns and patient journey of stage III non-small-cell lung cancer patients Observational Study KINDLE HCG KR Closed
187 2019 Dr. Shekar Patil A Phase III, Multicentre ,Randomised, Double-Blind,Placebo-Controlled Study Of Atezolizumab (ANTI-PD-L1 Antibody) In Combination with Paclitaxel Compared With Placebo With Paclitaxel For Patients With Previously Untreated Inoperable Locally Advanced Or Metastatic Triple Negative Breast Cancer.” III MO39196 HCG KR Closed
188 2019 Dr. Satheesh C T A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Efficacy, Safety, and Immunogenicity of Proposed Rituximab Biosimilar (DRL_RI) with MabThera® in Subjects with Previously Untreated, Stage II-IV, Cluster of Differentiation (CD)20-Positive, Low Tumour Burden Follicular Lymphoma.” III RI-01-006 HCG Closed
189 2019 Dr. Satheesh C T An open-label, randomized, Multiple Dose, Steady State, two treatments, three periods, three sequence, three way, Reference Replicated crossover bioequivalence study of 15 mg Trifluridine/6.14 mg Tipiracil and 20 mg Trifluridine/8.19 mg Tipiracil tablet in Metastatic colorectal cancer patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and if KRAS wild type, an anti-EGFR therapy, under fed conditions. BA/BE ARL/CT/18/004 HCG Closed
190 2019 Dr.Govind Babu A phase II randomized study of the combination of Ribociclib plus goserelin acetate with Hormonal Therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with hormone receptor positive/HER 2 negative inoperable locally advanced or metastatic breast cancer-CLEE011A3201C II CLEE011A3201C HCG KR Closed
191 2019 Dr. Satheesh C T A Prospective, Randomized, Multicentre, Comparative, open-label, Parallel study to evaluate the Efficacy, Safety and Pharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3256; Cadila Healthcare Ltd) and Reference-Trastuzumab Emtansine (Kadcyla®, a product of Roche) in HER2- Positive Metastatic Breast Cancer Patients III TDM1.17.001.03 HCG KR Closed
192 2019 Dr. Satheesh C T Randomized, Assessor-Blind, Multicentre, Parallel Group, Two Arms, Clinical Study to Assess the Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Test Product, Zydus) in comparison with Rituximab (Reference Product, Roche/Genentech) in Patients with Diffuse Large B Cell Lymphoma (DLBCL). III RITU.17.001.01.PROT HCG KR Closed
193 2019 Dr. Srinivasa B J Tissue biopsy Replacement with unique Evaluation of circulating bio-markers for morphological evaluation and clinically relevant molecular typing of malignancies from Blood sample.” Observational Study HCG KR Closed
194 2019 Dr. Srinivasa B J “Circulating Tumor Cell (CTC) Assay as A Surrogate for Tissue Diagnosis of Suspected Breast Cancer.” Observational Study HCG KR Closed
195 2019 Dr. Satheesh C T “A Research on Currently Avaialble Method and Novel Technology of Micro RNA Quantification In Different Cancer Screenings Observational Study HCG KR Closed
196 2019 Dr. Satheesh C T “Collection of Blood Samples from Subjects with Lung Cancer or Acute Myeloid Leukemia for Immunophenotypic Characterization and Evaluation of Anti-tumor Activity of Peripheral Blood T cells. Observational Study SY-1901 HCG KR Closed
197 2019 Dr. Shekar Patil A Long-term Follow -up study for Cardiac Safety in the patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC. Observational Study SB3-G31-BC-E HCG KR Closed
198 2020 Dr.Satheesh CT “Efficacy and Tolerability of Sequencing Weekly Paclitaxel and Doxorubicin +Cyclophosphamide Regimen in HER-2 negative Breast Cancer.” III Closed
199 2020 Dr. Satheesh C T A Phase IIb/III, Randomised, Double-blind, Placebo-controlled, Multicentre, Study of CA-170 in Combination with Chemotherapy and Radiation in Patients with Unresectable Stage III or IVa Non-Squamous Non-Small Cell Lung Cancer (ASIAD-2).” IIB/III CA-170-301 HCG KR Closed
200 2020 Dr. Vishal Rao An open label phase 1 clinical trial to evaluate safety and tolerability of Cytokine cocktail therapy in healthy volunteers from healthy donors (derived by T cells) I IMD/CoV/004/2020 HCG KR Closed
201 2020 Dr. Ajai Kumar Phase I clinical trial to evaluate safety and efficacy of low-dose radiation therapy as a focal anti-inflammatory treatment for patients with pneumonia or SARS, associated with COVID-19 infection” I TMT/COVID/002/2020 HCG KR Closed
202 2020 Dr. Shekar Patil PIK3CA Registry – A descriptive study of PIK3CA mutations in patients with HR+/Her 2- advanced breast cancer Observational Study CBYL719C2401 HCG KR Closed
203 2020 Dr. Veena R De-Identified Sample Acquisition Protocol for 100 Characterized Colorectal Carcinoma and Breast Cancer Tumor FFPE Blocks Observational Study ADX P#02  HCG KR Closed
204 2020 Dr. Satheesh C T Collection of Blood Samples from Subjects of Breast, Lung and other Cancers for Liquid Biopsy Assay Validation of Peripheral Blood Mononuclear Cells Observational Study SLS-ERL-01 HCG KR Closed
205 2020 Dr. Sachin suresh Jadha An Open label, Multi-Centre, Randomized, Two-treatment, Multi dose, Parallel, Comparative Bioavailability Study of Bortezomib Injection 3.5 mg/0.2 ml and VELCADE 3.5 mg powder for solution for injection at a dose of 1.3 mg/m2 in Multiple Myeloma patients.” BA/BE 727/18 HCG KR Closed
206 2021 Dr. Srinivasa B J A randomized, open label, multi-center, two-treatment, two-period, two-sequence, two-way cross-over, multiple dose, steady-state Bioequivalence (BE) study of Pazopanib HCl 200mg Tablets at a dose of 800 mg (4 * 200 mg tablets) of Torrent Pharmaceuticals Ltd., India with VOTRIENT® (Pazopanib HCl 200mg) Tablets at a dose of 800 mg (4 * 200 mg tablets) of Novartis Pharmaceuticals Corporation, USA in subjects with Advanced renal cell carcinoma under fasting condition BA/BE CBCC/2020/002 CBCC CBCC HCG KR Closed

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