Conditions: Solid Tumor Advanced Cancer
Keywords: Advanced solid cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: no

Brief summary:
The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan in combination with capecitabine

Detailed description:
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

Arms:
arm 1: Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

* Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5
* HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5
* Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1\~Day14

Interventions: intervention 1: Oratecan and Capecitabine
Intervention descriptions: intervention 1: Oratecan in combination with Capecitabine

* Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1\~Day5
* HM30181AK Tablet - Fixed dose 15 mg, Day1\~Day5
* Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1\~Day14

Protocol document: