A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

Phase 1 Completed 36 enrolled Celgene Corporation

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.

Timeline

Start: 2006-07-01
Primary completion: 2008-07-01
Completion: 2008-07-01

Publications

Results Jones SF, Infante JR, Spigel DR, Peacock NW, Thompson DS, Greco FA, McCulloch W, Burris HA 3rd. Phase 1 results from a study of romidepsin in combination with gemcitabine in patients with advanced solid tumors. Cancer Invest. 2012 Jul;30(6):481-6. doi: 10.3109/07357907.2012.675382. Epub 2012 Apr 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	800 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Subject	Romidepsin	Peptide	7 mg/m2	Intravenous
Subject	Romidepsin	Peptide	10 mg/m2	Intravenous
Subject	Romidepsin	Peptide	12 mg/m2	Intravenous

A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications