Status:
COMPLETED
Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.
Detailed Description
Besides the main objective, there are 4 other objectives as follows: 1. To determine dose-limiting toxicity (DLT) of HM781-36B 2. To determine Maximum Tolerated Dose (MTD) of HM781-36B 3. To determin...
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 :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01455584
Start Date
June 1 2011
End Date
May 1 2013
Last Update
May 23 2013
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea