drugset / Trial / NCT00081536

Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

NCT00081536 ↗

Phase 1/2 Unknown 105 enrolled Aronex Pharmaceuticals
Non-randomizedCrossoverOpen-labelTreatment

Summary

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.

Timeline

Start
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Primary completion
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Completion
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Drugs

EvaluationDrugModalityDoseRoute
Subject Aroplatin Small molecule — —
Subject Capecitabine Small molecule — —

Indications