Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors
NCT ID: NCT01455584
Last Updated: 2013-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2011-06-30
2013-05-31
Brief Summary
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Detailed Description
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1. To determine dose-limiting toxicity (DLT) of HM781-36B
2. To determine Maximum Tolerated Dose (MTD) of HM781-36B
3. To determine the effect of food on the pharmacokinetics after dosed HM781-36B continuously
4. To evaluate anticancer activity of HM781-36B in patients with advanced solid malignancies
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HM781-36B
HM781-36B
HM781-36B tablets
Q1X28D/4W for HM781-36B tablets
Interventions
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HM781-36B tablets
Q1X28D/4W for HM781-36B tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy
3. 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
4. Aged ≥19
5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2
6. A life expectancy greater than 12 weeks
7. Adequate bone marrow, renal and liver function.
8. 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
2. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT
3. Patients who have GI malabsorption or difficulty taking oral medication
4. Patients who have psychiatric or congenital disorder
5. Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments
6. Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-PHI-102
Identifier Type: -
Identifier Source: org_study_id
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