Advanced Solid Tumors Clinical Trial
Official title:
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
| Active, not recruiting |
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