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Completed Clinical Studies

S.no Project title
1 A randomized, open label, two treatment, three period, three sequence, single dose, replicated crossover, bioequivalence study of doxorubicin hydrochloride liposome injection 2mg/ml (50mg/m2 dose) of sun pharmaceutical industries limited and caelyx (doxorubicin hydrochloride) liposome injection 2 mg/ml (50 mg/m2 dose) of janssen- cilag international nv, in patients with metastatic breast cancer/advanced ovarian cancer, under fed (standardized non high-fat meal) conditions
2 A randomised, doubleblind, placebocontrolled, phase III study to evaluate the efficacy and safety of afatinib (BIBW 2992) as adjuvant therapy after chemoradiotherapy in primary unresected patients with stage III, IVa, or IVb locoregionally advanced head and neck squamous cell carcinoma.
3 A multi-centre, randomized, open-label, single dose, two-treatment, three-period, three-sequence, partial replicate, crossover, pivotal bioequivalence study of Test capecitabine 500 mg tablet manufactured by Reliance Life Sciences Pvt. Ltd., India with Xeloda® (capecitabine 500 mg) manufactured by Roche Pharma AG, Germany in adult, human, cancer patients under fed condition.
4 Prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-029 /Neulasta® (Neulastim®) when given subcutaneously in patients with Chemotherapy Induced Neutropenia
5 Prospective, multi-centre, randomized, open label, two arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety and Pharmacokinetics of R-TPR-023/AvastinTM when given intravenously in patients with Metastatic Colorectal Cancer
6 Protocol No: RLS/TP/2011/05 “ Prospective, Multi-centre, randomized, open label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-0-16/Herceptin (Herclon) when given intravenously in patients with metastatic HER2-Overexpressing Breast Cancer
7 Protocol Title and No.: Prospective, multi-centric, open-label, two-arm, parallel group, active-control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera®(Ristova®) in patients with Non-Hodgkin’s Lymphoma (RLS/TP/2010/07)
8 Sandoz LAEP 06-302 – Sandoz Protocol LA-EP06-302: Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®
9 AP311736: Adjuvant Axitinib treatment of Renal Cancer: A Randomized Double-blind Phase.3 study of Adjuvant Axitinib vs. Placebo in Subjects at High risk of Recurrent RCC.
10 Collection of blood samples from patients with primary or relapsed/refractory CD 20+ B cell Non Hodgkins Lymphoma for development and Bio analytical methods for BVX-20
11 A multinational, multicenter, randomized, double blind study comparing theEfficacy and safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism (VTE) in patients undergoing Major Abdominal Surgery.
12 Randomized, phase III-b, multi center, open label, parallel study of Enoxaparin given concomitantly with chemotherapy Vs Chemotherapy alone in patients with inoperable gastric and gastro-oesophageal cancer.
13 A Prospective, Randomized, Multiple-Dose, Multi-Center, Comparative, Parallel Clinical Study to Evaluate the Efficacy, Safety, Immunogenicity and Pharmacokinetics of an Intravenous Infusion of Bevacizumab (Test product, Hetero) and Reference Medicinal Product (Reference product, Roche) Administered in Combination with Standard Chemotherapy in Patients of Metastatic Colorectal Cancer.
14 Mylan – Cliantha MYL-1402O-3001 : Multicentre, Double-Blind, Randomized, Parallel-Group Study to Assess the Efficacy and Safety of MYL-1402O Compared With Avastin®, in the First -line treatment of Patient with Stage IV Non-Squamous Non-Small Cell Lung Cancer.
15 TevaPharma -Lotus –Study Title: An Open-Label, Multicentric, Randomized, Two Treatment, Three Period, Three Sequence, Semi-Replicate, Cross-over, Comparative Bioavailability Study of Doxorubicin Hydrochloride Liposomal Injection 20 mg/10mL (2mg/ml), concentrate for solution for infusion manufactured by Teva Pharmachemie, Netherlands with Caelyx 20 mg/10ml (2mg/ml) [Doxorubicin Hydrochloride Liposomal Injection], concentrate for solution for infusion of Janssen-CilagInternational NV, Belgium in advanced ovarian cancer and/or metastatic breast cancer patients under fasting condition. CT/DOX/1602.
16 Dr. Reddy’s – Lambda Study No.0076-17 –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 and/or metastatic breast cancer patients under fed condition.
17 Reference: Protocol no: CLR_16_13 – Sun Pharma Study Title: 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.
18 Intas -Lambda Therapeutic Research Ltd Study No.471-13-A Prospective, Adaptive, Randomized, Open-Label, MulticenterClinical Trial to assess the Efficacy and Safety of Fixed DoseCombination of Capecitabine & Cyclophosphamide in Patients of Metastatic Breast Cancer with failure of Anthracyclineand/or Taxane Chemotherapy.
19 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.
20 A randomized double-blind study in two parts

  • PartA – Comparing two humanized monoclonal antibodies that target VEGF in combination with mFOLFOX6 in patients with non-resectable metastatic colorectal cancer (mCRC)
  • PartB – Comparing two humanized monoclonal antibodies that target VEGF in combination with pemetrexed and carboplatin in recurrent or advanced non-squamous non-small cell lung cancer(NSCLC)
21 A Phase 3 Randomized, Double-Blind Study Of Pf-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin For The First-Line Treatment Of Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer