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
Besides the main objective, there are 4 other objectives as follows:
- To assess the safety of Oratecan in combination with capecitabine
- To evaluate anticancer activity of Oratecan in combination with capecitabine in
patients with advanced solid malignancies
- To characterize the pharmacokinetics of Oratecan and its metabolites following oral
administration of OratecanTM in combination with capecitabine
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD determination
Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1
Yes
Korea: Food and Drug Administration
HM-OTE-103
NCT01463982
December 2010
December 2012
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