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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01344876
First received: April 26, 2011
Last updated: May 20, 2015
Last verified: May 2015
Results First Received: April 8, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Non-Hodgkin Lymphoma
Acute Myeloid Leukemia
Acute Lymphoid Leukemia
Chronic Myeloid Leukemia
Intervention: Drug: OPB-51602

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
OPB-51602: 1mg/Day OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: 2mg/Day OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: 3mg/Day OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: 4mg/Day OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
OPB-51602: 6mg/Day OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

Participant Flow:   Overall Study
    OPB-51602: 1mg/Day   OPB-51602: 2mg/Day   OPB-51602: 3mg/Day   OPB-51602: 4mg/Day   OPB-51602: 6mg/Day
STARTED   4   3   4   6   3 
COMPLETED   3   3   3   3   2 
NOT COMPLETED   1   0   1   3   1 
Adverse Event                0                0                0                0                1 
Withdrawal by Subject                0                0                1                0                0 
Definite progression of primary disease                1                0                0                3                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OPB-51602

OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle

OPB-51602: once daily during the treatment period


Baseline Measures
   OPB-51602 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (6.5) 
Gender 
[Units: Participants]
 
Female   7 
Male   13 
Region of Enrollment 
[Units: Participants]
 
Japan   20 


  Outcome Measures
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1.  Primary:   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) ]

2.  Primary:   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) ]

3.  Secondary:   Treatment Response   [ Time Frame: From first dose of study medication to withdrawal examination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Leader of Department of “Small Global” Clinical Development
Organization: Otsuka Pharmaceutical Co., Ltd
phone: +81-3-6361-7366



Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov 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
Health Authority: Japan: Ministry of Health, Labor and Welfare