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A Phase I Clinical Trial to Determine the Maximum Tolerated Dose and to Assess the Safety of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Cancer
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine
Details
| Lead sponsor | Hanmi Pharmaceutical Company Limited |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 21 |
| Start date | 2010-12 |
| Completion | 2013-12 |
Conditions
- Solid Tumor
- Advanced Cancer
Interventions
- Oratecan and Capecitabine
Primary outcomes
- Dose Limiting Toxicity Assessment and Maximum Tolerated Dose Determination — Cycle 1 (21 days)
If Dose Limiting Toxicity(DLT) was not observed in the third subject at a dose level from the first study drug dosing date (Day 1) to the end of Cycle 1(21 days), increase the dose to the next level and enroll subjects; enrollment up to Level 4 was allowed. (NCI-CTCAE version 3.0)
Countries
South Korea