Solid Tumor Clinical Trial
Official title:
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
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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