Clinical trial · Interventional
Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
A Dose-escalation Trial to Investigate the Safety and Tolerability of OPB-51602 in Patients With Relapsed or Refractory Hematologic Malignancies (Phase 1)
NCT01344876CI-TRIAL-00018201completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the maximum tolerated dose (MTD) of OPB-51602
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPB-51602 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OPB-51602
- description
- OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
- interventionNames
- Drug: OPB-51602
Primary outcomes (2)
- measure
- Subjects With Treatment Emergent Adverse Events
- timeFrame
- From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
- description
- 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.
- measure
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
- timeFrame
- From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a confirmed diagnosis of MM, NHL, AML, ALL or CML. 2. Patients who are responsive or have relapsed following standard treatment 3. Patients capable of providing written informed consent 4. Japanese patients age 20 to 75 years (inclusive) at time of informed consent 5. ECOG performance status score of 0-1 6. Life expectancy of at least 3 months 7. Adequate vital organ function 8. 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: 1. Patients with other primary malignant tumors 2. Symptomatic CNS involvement 3. Ongoing or active infection, or complication that is not controllable by medication or other means 4. Complication of uncontrolled cardiac disease 5. Female patients who are pregnant, possibly pregnant, or lactating, or who wish to become pregnant during the study period 6. 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
References
Publications (0)
Data not yet available
No reference posted for this study.