A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objectives of this study are to determine the MTD and safety profile of OPB-51602 in subjects with relapsed or refractory hematologic malignancie.
[Safety]DLT, adverse events, body weight, Eastern Cooperative Oncology Group Performance Status, vital signs, 12-lead ECG, pulse oximetry, and laboratory tests [Pharmacokinetics]Plasma concentrations and pharmacokinetic parameters of OPB-51602 and its metabolites
Japan: Ministry of Health, Labor and Welfare