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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.