Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies

Phase 1

Completed

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

Recruitment & Eligibility

Inclusion Criteria

Histologically or cytologically confirmed advanced solid tumor
Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved
Aged ≥19
Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
A life expectancy greater than 12 weeks
Adequate bone marrow, renal and liver function.
Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures

Exclusion Criteria

Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.
Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
Patients who have GI malabsorption or difficulty taking oral medication
Patients who have psychiatric or congenital disorder Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)

Arm && Interventions

Group	Intervention	Description
Oratecan and Capecitabine	Oratecan and Capecitabine	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

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR), Response Rate (RR) and Disease Control Rate (DCR)	tumor response evaluation can continue to receive the study drug until PD confirmation	by RECIST guideline Objective response rate = (Number of subjects with best overall response as confirmed CR or PR / Total number of subjects)\100. Response rate = (Number of subjects with best overall response as CR or PR / Total number of subjects)\100. Disease control rate = (Number of subjects with best overall response as confirmed CR or PR or SD / Total number of subjects)\*100.