Phase 1b indibulin-capecitabine trial ended early after no dose-limiting toxicity seen
A Phase 1b trial testing indibulin combined with capecitabine in patients with advanced solid tumors was terminated, according to its registry record on ClinicalTrials.gov (NCT00726687, sponsor study ID IBL1005).
A Phase 1b trial testing indibulin combined with capecitabine in patients with advanced solid tumors was terminated, according to its registry record on ClinicalTrials.gov (NCT00726687, sponsor study ID IBL1005). The stated reason was that no dose-limiting toxicity was observed1, and the sponsor concluded the study after 3 subjects at the higher dose level, leaving the optional 10-subject expansion cohort unenrolled1.
The study began on June 19, 2008, with primary and overall completion both dated September 29, 2009, according to the record. It was first posted August 1, 2008, and the record was last updated September 30, 2026. The lead sponsor listed is Alaunos Therapeutics.
Dosing called for three subjects treated at each dose level, with the maximum administered dose reached if dose-limiting toxicity occurred in two or more of six or fewer subjects, at which point the dose would be reduced to the prior level to define the maximum tolerated dose1. Indibulin was dosed at 400-600 mg taken twice daily, with capecitabine (Xeloda) dosed at 875 mg/m2 to 1250 mg/m2 twice daily for 14 days of a 21-day cycle1.
Total enrollment reached 7 participants (actual)1, across three U.S. sites in Indianapolis, Indiana; Las Vegas, Nevada; and Vancouver, Washington1. The eligibility criteria reference informed consent in compliance with ZIOPHARM policies and the Institutional Review Board having jurisdiction over the site1.
Fact check notes
- Checker's noteThe entry states the trial was planned for 13 participants, but the source never specifies a planned total enrollment figure; this number appears to be an inference (3 + 10 expansion) not explicitly supported by the record.
- Sentence removed
The trial was designed as a 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.
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Its main goal was to determine the maximum tolerated dose and optimal dosing schedule of indibulin in combination with capecitabine, with secondary goals covering dose-limiting toxicity, safety and tolerability, and preliminary activity of the combination.
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