Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
This study has been completed.
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
First received: April 26, 2011
Last updated: May 20, 2015
Last verified: May 2015
To determine the maximum tolerated dose (MTD) of OPB-51602
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Chronic Myeloid Leukemia
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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.
| Study Start Date:
| Study Completion Date:
| 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
|Ages Eligible for Study:
||20 Years to 75 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML.
- Patients who are responsive or have relapsed following standard treatment
- Patients capable of providing written informed consent
- Japanese patients age 20 to 75 years (inclusive) at time of informed consent
- ECOG performance status score of 0-1
- Life expectancy of at least 3 months
- Adequate vital organ function
- Patients who, together with their partner, are willing and capable of using an appropriate method of contraception throughout the trial period and until at least 12 weeks after final IMP administration
- Patients with other primary malignant tumors
- Symptomatic CNS involvement
- Ongoing or active infection, or complication that is not controllable by medication or other means
- Complication of uncontrolled cardiac disease
- Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period
- Patients who have received another study drug, or who have received chemotherapy, immunotherapy, cytokine therapy, surgery, or radiotherapy for treatment of the primary disease, within 4 weeks prior to enrollment
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344876
|Nagoya, Japan |
|Tokyo, Japan |
Otsuka Pharmaceutical Co., Ltd.
||Otsuka Pharmaceutical Co., Ltd.
History of Changes
|Other Study ID Numbers:
JapicCTI-111478 ( Other Identifier: JAPIC )
|Study First Received:
||April 26, 2011
|Results First Received:
||April 8, 2015
||May 20, 2015
Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
multiple myeloma [MM]
non-Hodgkin lymphoma [NHL]
acute myeloid leukemia [AML]
acute lymphoid leukemia [ALL]
chronic myeloid leukemia [CML]
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 21, 2017
Leukemia, Myeloid, Acute
Neoplasms, Plasma Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases
Bone Marrow Diseases