CIMET’s Inamdar Multispeciality Hospital

Sr. No-15, Behind KPCT Mall, Fatima Nagar, Wanawadi, Pune-411040

PI Name: Dr. Minish Jain( Medical Oncologist)

Co-I Name: Dr. ShaileshNaik ( Surgical Oncologist )

1. NIVO.22.001: "A Phase III, Prospective, Randomized, Multicenter, Comparative, Double blind, Parallel-group Study to Investigate the Efficacy, Safety, and Pharmacokinetics of ZRC-3276 Versus Opdivo® (Nivolumab) in Subjects with locally advanced or Metastatic Non-Small Cell Lung Cancer."

2. PERT.21.001: “A Prospective, Randomized, Multicenter, Comparative, Double-blind, Parallelstudy to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Test Pertuzumab (ZRC-3277, Zysud Lifesciences Ltd., (Formerly known as a Cadila Healthcare Ltd.)) with Reference Pertuzumab (Perjeta®, Genentech Inc.,) in Previously Untreated Patients with HER2 Positive Metastatic Breast Cancer.”

3. PF-114-02: “A multicenter, open-label, randomized, phase III clinical trial to evaluate efficacy and safety of PF-114 versus imatinib at 600 or 800 mg daily in adult patients with Philadelphia chromosome positive (Ph+) Chronic Myeloid Leukemia (CML) in the chronic phase (CP) resistant to Imatinib at daily doses of 400 or 600 mg.”

4. CBCC/2022/003: An open label, multicenter, balanced, randomized, two-treatment, four-period, two-sequence, full replicate crossover, single dose, pharmacokinetic bioequivalence study of Capecitabine Tablets USP, 500 mg of Novugen Oncology Sdn. Bhd. with Xeloda® (Capecitabine) 500 mg Film-Coated Tablets manufactured by Roche Pharma AG, Germany following single oral dose of 2000 mg (4 X 500 mg) in adult human cancer patients under fed conditions.

5. CBYL719CIN01: ALPelisibINdia Safety STudy (ALPINIST): a Phase IV, prospective, multicenter, open-label, non-comparative, interventional study to assess the safety of alpelisib plus fulvestrant, in men and post-menopausal women with HR positive, HER2-negative, advanced breast cancer (aBC) with a PIK3CA mutation, whose disease has progressed on or after endocrine based treatment.

6. CINC280AIN01: A Prospective, Multicenter, Open-label, Phase IV, Interventional Study to Assess the Safety and Efficacy of Capmatinib in Indian Patients with Mesenchymal-Epithelial Transition (MET) exon 14 Skipping Mutation Positive Advanced Non-Small Cell Lung Cancer (NSCLC).

7. IRIN-IJL-1001: “An open-label, randomized, multi-center, three-period, three-treatment, three-sequence, single-dose, crossover, pharmacokinetic study of Mylan’s Irinotecan Liposomal Injection compared with Ipsen biopharmaceuticals Inc.’s Onivyde (Irinotecan liposome injection) and Les LaboratoiresServier'sOnivyde in combination with 5- fluorouracil (5-FU) and leucovorin (LV) in patients with metastatic adenocarcinoma of the pancreas, previously treated with gemcitabine.”

8. C2A03229: A Double Blind, Multicenter, Randomized, Three-Treatment, Three-Period, SixSequence, Steady-State Bioequivalence Study of Test Product (A) Olaparib Tablets 150mg (2*150 mg tablet ofNatco Pharma Limited, India with Reference Product (B1) Lynparza tablets (Olaparib) 150 mg (2*15mgtablets) of AstraZeneca do BrasilLtdaand Reference Product (B2)PrLYNPARZA® Olaparib Tablets 150 mg (2*150 mg tablets)of AstraZeneca Canada Inc. in Adult Male and Female Patients with Ovarian Cancer orBreast Cancer or Prostate Cancer Under Fed Condition.

9. C2A03014: A Double Blind, Multicenter,Randomized,Three-Treatment,Three-Period,Six-Sequence,Steady- State Bioequivalence Study of Test Product (A) OlaparibTablets 150 mg (2*150 mg tablets) of Nacto Pharma Limited,India with Reference Product (B1) Lynparzatablets (Olaparib) 150 mg (2*150 mg tablets) ofAstraZeneca do BrasilLtda and Reference Product(B2) PrLYNPARZA® Olaparib Tablets 150 mg (2*150mg tablets) of AstraZeneca Canada Inc. in Adult Maleand Female Patients with Ovarian Cancer or Breast Cancer or Prostate Cancer Under Fasting Condition.

10. CSC-CT-021: “A multi-center, open-label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady-state bioequivalence study of PazopanibHCl Tablets 200 mg (4 Tablets X 200 mg) of MSN Laboratories Private Limited, India compared with Votrient® Tablet 200mg (4 Tablets X 200 mg) of Novartis Pharmaceuticals Corporation, USA in Advanced renal cell carcinoma patients who are already receiving PazopanibHCl tablets in standard therapy, and who are tolerating a stable dosing regimen of 800 mg/day under fasting conditions.”