A Dose Ascending Study of Gemcitabine Elaidate (CO-101) in Combination With Cisplatin

Summary

The purpose of the first part of the study is to evaluate the safety, tolerability, and pharmacokinetics of ascending doses of gemcitabine elaidate in combination with cisplatin given to patients with advanced solid tumors, and to select a dose for further evaluation in the second part of the study. The purpose of the second part of the study is to determine the safety, tolerability, and exploratory clinical activity of gemcitabine elaidate in combination with cisplatin given to patients with Stage IIIb/IV non-small-cell lung cancer (NSCLC).

Timeline

Start

2012-07

Primary completion

2013-05

Completion

2013-06

Outcome

Outcome not reported

Stopped: “Registrational study did not meet endpoint so entire program (including CO-101-011) was terminated.”

Drugs

Indications