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Phase I Study of OPB-51602 in Patients With Hematologic Malignancies

Primary Purpose

Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OPB-51602
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma [MM], non-Hodgkin lymphoma [NHL], acute myeloid leukemia [AML], acute lymphoid leukemia [ALL], chronic myeloid leukemia [CML]

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPB-51602

Arm Description

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

Outcomes

Primary Outcome Measures

Subjects With Treatment Emergent Adverse Events
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)
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
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.

Full Information

First Posted
April 26, 2011
Last Updated
May 20, 2015
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01344876
Brief Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Chronic Myeloid Leukemia
Keywords
multiple myeloma [MM], non-Hodgkin lymphoma [NHL], acute myeloid leukemia [AML], acute lymphoid leukemia [ALL], chronic myeloid leukemia [CML]

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPB-51602
Arm Type
Experimental
Arm Description
OPB-51602 1, 2, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
Intervention Type
Drug
Intervention Name(s)
OPB-51602
Intervention Description
once daily during the treatment period
Primary Outcome Measure Information:
Title
Subjects With Treatment Emergent Adverse Events
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.
Time Frame
From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Title
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Description
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).
Time Frame
From first study medication to on Day 31 (after repeated 28 days medication from Day 4 to 31)
Secondary Outcome Measure Information:
Title
Treatment Response
Description
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.
Time Frame
From first dose of study medication to withdrawal examination

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Nagoya
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Phase I Study of OPB-51602 in Patients With Hematologic Malignancies

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