Phase 1
N=20
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
Multiple Myeloma · Non-Hodgkin Lymphoma · Acute Myeloid Leukemia · Acute Lymphoid Leukemia · Chronic Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT01344876 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jun 2015
Primary outcome: Primary: Subjects With Treatment Emergent Adverse Events — 20 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- OPB-51602 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Male
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects With Treatment Emergent Adverse Events |
20 | — |
| PRIMARY Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) |
0; 0; 0; 0; 1 | — |
| SECONDARY Treatment Response |
— | — |
Summary
To determine the maximum tolerated dose (MTD) of OPB-51602
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01344876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.