drugset / Trial / NCT00081536
Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies
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
- —
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aroplatin | Small molecule | — | — |
| Subject | Capecitabine | Small molecule | — | — |