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Vishakapatnam

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Vishakapatnam
Sl. No. Principal Investigator Co-Investigator Study Title Phase Protocol No Indication Study Status
1 Dr. Bhaskar Bhuvan Dr. Muralidhar Bora A Multicenter, Double-Blind, Randomized, Parallel-Group, Active-Controlled, Two Part, Phase III, Global Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BP02 (Trastuzumab) in comparison with Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC) and HER2-Positive Metastatic Breast Cancer (MBC). Phase 3 CR201-18 Her 2+ MBC Ongoing with Recruitment
2 Dr. Pradeep Bhaskar Dr. Bhaskar Bhuvan A multi-centric, open label, single arm study to evaluate the effect of energy dense protein supplement with immune nutrients on cachexia in cancer patients undergoing chemotherapy and/or radiotherapy. Phase 4 CBCC-2020-016 GI, LC, HNC RecruitmentCompleted
3 Dr. Bhaskar Bhuvan Dr.Sanketh Kotne Standard chemotherapy Versus Cancer Stem Cell Assay Directed Chemotherapy in Recurrent Platinum Resistant Ovarian Cancer. NA CG03-EOC Ca. Ovary Ongoing with Recruitment
4 Dr. Muralidhar Bora Dr. Bhaskar Bhuvan A phase II clinical study to evaluate the efficacy and safety of NRC-2694-A in patients with Recurrent Head and Neck Squamous cell carcinoma. Phase 3 NAT2694P2 HNC Ongoing with Recruitment
5 Dr. Pavan NA Collection of blood and tissue samples from subjects diagnosed with Esophageal Cancer to evaluate biomarker expression profiles. NA SLS-GNE-01 Ca. Esophagus Ongoing with Recruitment
6 Dr. Bhaskar Bhuvan NA Collection of blood samples from subjects diagnosed with Non-Small Cell Lung Carcinoma to evaluate biomarker expression profiles NA SLS-GNE-02 NSCLC Ongoing with Recruitment
7 Dr. Vijaya Aditya Dr. Bhaskar Bhuvan A Multicentric, Open-label, Randomized, Two Period, Two Treatment, Two Sequence, Crossover, Multiple Dose, Ste-ady state Bioequivalence Study of Sunitinib Malate Capsules 50 mg of Eugia Pharma Specialities Limited (A Joint venture of Aurobindo Pharma Limited & Celon Laboratories Limited), India (Test) with Sutent® (Sunitinib Malate) capsules 50 mg of Pfizer Labs, USA (Reference) in adult patients with advanced renal cell carcinoma already receivi-ng stable dose of Sunitinib Malate Capsules 50 mg under fasting conditions BA/BE CR194-18 RCC On Hold
8 Dr. Vijaya Aditya Dr. Sanketh Kotne An Open-Label, Randomized, Two-Period, Two-Treatment, Two-Sequence, Crossover, Multiple-Dose, Steady State Multicentre, Bioequivalence Study of Sunitinib Malate Capsules 50 mg of Oncogen Pharma (Malaysia) Sdn. Bhd. and ‘SUTENT®’(Sunitinib Malate) Capsules 50 mg of Pfizer Labs in Subjects with Gastrointestinal Stromal Tumor or Advanced Renal Cell Carcinoma under Fasting Conditions BE C2A00507 RCC Ongoing with Recruitment
9 Dr. Sanketh Kotne Dr. Bhaskar Bhuvan A phase III, two arm, multi centric, randomised, open label, parallel study to compare pharmacodynamics of Goserelin 10.8 mg Injection (Eurofarma Laboratórios S.A) administered subcutaneously with the reference drug ZOLADEX® 10.8 mg Injection (AstraZeneca) in patients with advanced prostate cancer. Phase 3 1045-18 Prostate Ongoing with Recruitment
10 Dr. Sanketh Kotne Dr. Bhaskar Bhuvan A multicenter, open label, randomized, balanced, two treatment, two-sequence, four period, replicate 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. BE CRD/43 MBC Ongoing with Recruitment
11 Dr. Bhaskar Bhuvan Dr. Sanketh Kotne A multicenter, randomized, open label, two treatment, three period, reference replicated, single-dose, crossover, bioequivalence study of Azacitidine Tablets 300 mg manufactured by Teva, Czech Industries s.r.o.with ONUREG (Azacitidine) Tablets 300 mg manufactured by Celgene Corporation, USA under fasting condition in patients with a confirmed diagnosis of Acute Myeloid Leukemia in remission phase. BA/BE CT-AZAC-2003 AML Ongoing with Recruitment
12 Dr. Bhaskar Bhuvan Dr.Vijaya Aditya Efficacy, Safety, and Pharmaco-kinetics of Leuprolide Acetate for Injection 3.75mg (Depot) Administered in Subjects with Advanced Adenocarcinoma of Prostate: A Randomized, Active Controlled, Comparative, Open Label, Multi- Center, Phase 3 study BA/BE BSV_LEUPR_18_05 Ca Prostate Ongoing with Recruitment
13 Dr. Bhaskar Bhuvan Dr. Sanketh Kotne A randomized, open label, multi-centre, two-treatment, two-period, two-sequence, two-stage, multiple dose, steady-state, crossover, bioequivalence study of Olaparib tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (olaparib) tablets 150 mg (AstraZeneca Pharmaceuticals LP), in patients with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer under fasting condition. BE 21-VIN-0016 Ca Ovary/Breast Start with recruitment

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