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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. Identifier:
First received: April 26, 2011
Last updated: May 20, 2015
Last verified: May 2015
To determine the maximum tolerated dose (MTD) of OPB-51602

Condition Intervention Phase
Multiple Myeloma
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Chronic Myeloid Leukemia
Drug: OPB-51602
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

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.

Enrollment: 20
Study Start Date: April 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPB-51602
OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
Drug: OPB-51602
once daily during the treatment period


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts 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
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Please refer to this study by its identifier: NCT01344876

Nagoya, Japan
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01344876     History of Changes
Other Study ID Numbers: 266-10-001
JapicCTI-111478 ( Other Identifier: JAPIC )
Study First Received: April 26, 2011
Results First Received: April 8, 2015
Last Updated: 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:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphatic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases processed this record on April 27, 2017