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Study of Orally Administered TAK-960 in Patients With Advanced Nonhematologic Malignancies

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01179399
First received: August 9, 2010
Last updated: January 13, 2014
Last verified: January 2014
Results First Received: October 28, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Advanced Nonhematological Malignancies
Intervention: Drug: TAK-960

  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
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Reporting Groups
  Description
TAK-960 Given orally (PO) for 21 days of a 28-day treatment cycle.

Participant Flow:   Overall Study
    TAK-960  
STARTED     32  
COMPLETED     0  
NOT COMPLETED     32  
Adverse Event                 1  
Lack of Efficacy                 30  
Withdrawal by Subject                 1  



  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
TAK-960 Given orally (PO) for 21 days of a 28-day treatment cycle.

Baseline Measures
    TAK-960  
Number of Participants  
[units: participants]
  32  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     15  
>=65 years     17  
Age  
[units: years]
Mean ± Standard Deviation
  64.9  ± 9.77  
Gender  
[units: participants]
 
Female     14  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     20  
Spain     12  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of TAK-960   [ Time Frame: up to 12 months ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01179399     History of Changes
Other Study ID Numbers: C22001
Study First Received: August 9, 2010
Results First Received: October 28, 2013
Last Updated: January 13, 2014
Health Authority: United States: Food and Drug Administration