NCT00726687

Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.

Detailed description

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	indibulin	indibulin, dose escalation, 400-600 mg taken twice every day
DRUG	capecitabine	capecitabine, dose escalation, 875 mg/m2- 1250 mg/m2, taken twice daily for 14 days per 21 day cycle

Timeline

• Start date: 2008-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2008-08-01
• Last updated: 2012-07-19

Locations

3 sites across 1 country: United States