Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
|ClinicalTrials.gov Identifier: NCT01344876|
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma Non-Hodgkin Lymphoma Acute Myeloid Leukemia Acute Lymphoid Leukemia Chronic Myeloid Leukemia||Drug: OPB-51602||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
once daily during the treatment period
- 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) ]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) ]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 ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344876