Spots Global Cancer Trial Database for Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

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Trial Identification

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

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

Study ID: NCT00726687

Conditions

Advanced Solid Tumors

Interventions

indibulin

capecitabine

Study Description

Brief 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.