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Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma

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ClinicalTrials.gov Identifier: NCT00920790
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : September 25, 2012
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Adult T-cell Leukemia-lymphoma
Intervention: Biological: KW-0761

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 1 June 2009 through 9 November 2010

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
KW-0761 IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg

Participant Flow:   Overall Study
    KW-0761
STARTED   27 
COMPLETED   13 
NOT COMPLETED   14 
aggravation of general condition                14 



  Baseline Characteristics

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
KW-0761 IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg

Baseline Measures
   KW-0761 
Overall Participants Analyzed 
[Units: Participants]
 27 
Age 
[Units: Years]
Median (Full Range)
 64 
 (49 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  55.6% 
Male      12  44.4% 


  Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months. ]

2.  Primary:   Pharmacokinetics-Plasma KW-0761 Concentrations   [ Time Frame: 0 to 7 days post final dose ]

3.  Primary:   Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days)   [ Time Frame: 0 to 7 days post final dose ]

4.  Primary:   Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2)   [ Time Frame: 0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period). ]

5.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Baseline to response ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline to response ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Project Management Department, Development Division
Organization: Kyowa Hakko Kirin
e-mail: clinical.info@kyowa-kirin.co.jp


Publications of Results:

Responsible Party: Kyowa Hakko Kirin Co., Ltd
ClinicalTrials.gov Identifier: NCT00920790     History of Changes
Other Study ID Numbers: 0761-002
First Submitted: June 9, 2009
First Posted: June 15, 2009
Results First Submitted: July 9, 2012
Results First Posted: September 25, 2012
Last Update Posted: March 29, 2017