Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.
Advanced Solid Tumors
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors|
- toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Single arm designed to elicit Maximum Tolerated Dose
indibulin, dose escalation, 400-600 mg taken twice every dayDrug: capecitabine
capecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle
Other Name: Xeloda
The primary objective of the trial is to determine the maximum tolerated dose (MTD) and optimal dosing schedule of indibulin in combination with capecitabine in subjects diagnosed as having advanced solid tumors.
Secondary objectives include the determination of dose-limiting toxicity (DLT), safety and tolerability, and preliminary activity of this combination. In addition, biological activity of indibulin in combination with capecitabine will be evaluated.
Single arm, open label, Phase Ib, dose-escalation study of indibulin in combination with capecitabine in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with capecitabine is considered medically acceptable.
3 subjects will be treated at each dose level. When DLT occurs in 2 or more of 6 or fewer subjects, MAD has been reached and the dose will be reduced to the previous dosing level, which will be considered the MTD.
|United States, Indiana|
|Indianapolis, Indiana, United States|
|United States, Nevada|
|Las Vegas, Nevada, United States|
|United States, Washington|
|Vancouver, Washington, United States|
|Study Chair:||Jonathan Lewis, MD||Ziopharm|