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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Advanced Cancer; Solid Tumor

Treatments: Drug: Oratecan and Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01463982

HM-OTE-103

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Oratecan and Capecitabine

Experimental group

Description:

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

Treatment:

Drug: Oratecan and Capecitabine