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

NCT ID: NCT01463982

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-12-31

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

Conditions

Solid Tumor; Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Oratecan and Capecitabine

Intervention Type: DRUG

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

Interventions

Oratecan and Capecitabine

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

Intervention Type: DRUG

Other Intervention Names

Oratecan(HM30181AK + Irinotecan HCl) and Capecitabine

Eligibility Criteria

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.)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jina Jung, PhD

Role: STUDY_DIRECTOR

Hanmi Pharmaceuticals.Co.,Ltd

Locations

Hanmi Pharmaceuticals, Co., Ltd

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HM-OTE-103

Identifier Type: -

Identifier Source: org_study_id