Status:
COMPLETED
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Solid Tumor
Advanced Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01463982
Start Date
December 1 2010
End Date
December 1 2013
Last Update
April 23 2015
Active Locations (1)
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1
Hanmi Pharmaceuticals, Co., Ltd
Seoul, South Korea