Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
To determine the maximum tolerated dose (MTD) of OPB-51602
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Chronic Myeloid Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)|
- Subjects With Treatment Emergent Adverse Events [ Time Frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) ] [ Designated as safety issue: Yes ]Treatment emergent adverse events observed during outcome measure time frame. A Treatment Emergent Adverse Event was defined as an AE occurring after the start of IMP administration.
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31) ] [ Designated as safety issue: Yes ]DLT was defined as adverse events occurring during Cycle 1 and: (1) Grade 3 or higher nausea, vomiting, or diarrhea despite the use of anti-emetic or antidiarrheal drugs, (2) Grade 3 or higher non-hematologic toxicity, excluding alopecia, (3) AEs requiring interruption of the IMP for a total of 8 days or longer, (4) Grade 4 neutropenia lasting ≥ 8 days (not applicable for leukemia), (5) Grade 3 or higher febrile neutropenia or infection due to neutropenia (not applicable for leukemia), (6) Grade 4 thrombocytopenia or Grade 3 thrombocytopenia requiring platelet transfusion (not applicable for leukemia).
- Treatment Response [ Time Frame: From first dose of study medication to withdrawal examination ] [ Designated as safety issue: No ]
Assessment of the treatment response was evaluated according to internationally recognized response criteria for multiple myeloma, non-Hodgkin's lymphoma, acute myeloid leukemia, chronic myeloid leukemia.
"Response" was defined as at least partial response or partial remission (PR) according to the criteria for efficacy assessment.
|Study Start Date:||April 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
once daily during the treatment period
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344876