---
title: Phase I Study of OPB-51602 in Patients With Hematologic Malignancies
nct_id: NCT01344876
overall_status: COMPLETED
phase: PHASE1
sponsor: Otsuka Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Multiple Myeloma
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01344876.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01344876"
ct_last_update_post_date: 2015-06-08
last_seen_at: "2026-05-12T06:49:29.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase I Study of OPB-51602 in Patients With Hematologic Malignancies

**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)

**NCT ID:** [NCT01344876](https://clinicaltrials.gov/study/NCT01344876)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Otsuka Pharmaceutical Co., Ltd.
- **Conditions:** Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia
- **Start Date:** 2011-04
- **Completion Date:** 2014-04
- **CT.gov Last Update:** 2015-06-08

## Brief Summary

To determine the maximum tolerated dose (MTD) of OPB-51602

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 75 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **OPB-51602** (EXPERIMENTAL) — OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

## Interventions

- **OPB-51602** (DRUG) — once daily during the treatment period

## Primary Outcomes

- **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 Outcomes

- **Treatment Response** _(time frame: From first dose of study medication to withdrawal examination)_

## Locations (2)

- Nagoya, Japan
- Tokyo, Japan

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|nagoya||japan` — added _(2026-05-12)_
- `locations.|tokyo||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01344876.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01344876*  
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