Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile
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 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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD determination
Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
Yes
Korea: Food and Drug Administration
HM-PHI-102
NCT01455584
June 2011
May 2013
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