To determine the maximum tolerated dose (MTD) of OPB-51602
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
once daily during the treatment period
Unnamed facility
Nagoya, Japan
Unnamed facility
Tokyo, Japan
Subjects With Treatment Emergent Adverse Events
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.
Time frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
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).
Time frame: From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Treatment Response
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.
Time frame: From first dose of study medication to withdrawal examination
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