Department of Clinical Trial

Objectives
•To develop new drugs in collaboration with Pharmaceutical Industry. Project: 1
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus Cyclophosphamide, Vincristine and Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone, Followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma.
Sponsors: – Hexal AG, a Sandoz Company
Principal Investigator: – Dr. Kalyan Kusum Mukherjee
Co-Investigators: –
Dr. Suparna Mazumder
Dr. Indranil Ghosh
Dr. Partha Nath
Dr. Durga Prasad Nanda
Chief Study Co-ordinator:Subhabrata Dey
Study Co-ordinators: Somnath Chakraborty
Phlebotomist: Surya Kanta Roy.
Status: Ongoing.
No. of Patient Recruited: 2
No. of Patient Screened Failure:2
Project: 2
“A Multicenter, Open-Label, Randomized, Phase-II Study to Evaluate the Efficacy and Safety of NKTR 102 (PEG- Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Patients with Metastatic Colorectal Cancer (mCRC)” (Study Code: 08-PIR-03).”
Sponsors:
NEKTAR Therapeutics Ltd.
201 Industrial Road.
San Carlos, CA 94070, USA.
Principal Investigator: Dr. Kalyan Kusum Mukherjee.
Co-Investigators: Dr. Partha Nath, Dr. Durga Prasad Nanda
Chief Study Co-ordinator: Subhabrata Dey
Study Co-ordinators: Somnath Chakraborty, Moumita Banerjee
Phlebotomis: Surya Kanta Roy
Status: Ongoing.
No. of Patient Recruited: 16
No. of Patient Screened Failure: 2
Project: 4
An Open Label, Balanced, Randomized, Multicentre, Multiple-Dose, Two-Period, Two-Treatment, Two-Sequence, Steady State, Crossover Comparative Bioequivalence Study of Two Formulations of 6 – Mercaptopurine in Adult Subjects with Acute Lymphoblastic Leukaemia (ALL). (Study Code: 19960001)
Sponsors: Orion Corporation, Orion Pharma, P.O. Box 425, FI- 20101, Turku, Finland.
Principal Investigator: Dr. Kalyan Kusum Mukherjee
Co-Investigators: Dr. Partha Nath, Dr. Durga Prasad Nanda
Chief Study Co-ordinator: Subhabrata Dey
Study Co-ordinator: Somnath Chakraborty , Moumita Banerjee
Phlebotomist: Surya Kanta Roy
Status: Ongoing.
No. of Patient Recruited: 0
No. of Patient Screened Failure: 1
Project: 5
An Open Label Randomized, Multiple-Dose, Parallel Study to Evaluate Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension (Intas Pharmaceuticals Ltd.) and Taxol® (Paclitaxel Injection Concentrate, Bristol-Myers Squibb.) in Metastatic Breast Cancer Patients after failure of prior chemotherapy. (Study Code: 113-10)

Sponsors: Intas Pharmaceuticals Ltd.
2nd Floor, Chinubhai Center, Ashram Road. , 2nd Floor, Chinubhai Center, Ashram Road.
Principal Investigator: Dr. Kalyan Kusum Mukherjee
Co-Investigators: Dr. Partha Nath, Dr. Durga Prasad Nanda , Dr. Indranil Ghosh
Chief Study Co-ordinator: Subhabrata Dey
Study Co-Ordinator:Somnath Chakraborty, Moumita Banerjee ,
Moumita Banerjee.
Phlebotomist:Surya Kanta Roy
Status: Ongoing.
No. of Patient Recruited: 13
No. of Patient Screened Failure: 1