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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B.
Besides the main objective, there are 3 other objectives as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM781-36B | Experimental | Dose : 0.5mg, 1mg, 2mg, 4mg, 8mg, 12mg, 16mg, 20mg,... |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM781-36B | Drug | Q1DX14/2W for 3W HM781-36B |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD determination | Dose limiting Toxicity will be evaluated on Day 21 during Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
1) Patients with hematopoietic malignancies,uncontrolled infection, ileus, CNS metastasis.
2) Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3) Class III or IV heart failure (NYHA Class) or LVEF<40% 4) Patients who have GI malabsorption or difficulty taking oral medication 5) Patients who have psychiatric or congenital disorder 6) Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 7) Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.) 8) Subjects who have no intention of following the requirements of the protocol or the follow-up management. Subjects who cannot be followed up regularly due to psychological, social, family, logistic, and geographical reasons 9) Subjects who were administered with other investigational products within 30 days before screening.
10) Subjects who, in the investigator's opinion, cannot be participated.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2015 | |
| Reset | Jun 5, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2015 | Jun 5, 2015 |
| ID | Term |
|---|---|
| C557213 | HM781-36B |
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