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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01179399
Recruitment Status : Terminated
First Posted : August 11, 2010
Results First Posted : March 3, 2014
Last Update Posted : March 3, 2014
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Advanced Nonhematological Malignancies
Intervention: Drug: TAK-960

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
TAK-960 Given orally (PO) for 21 days of a 28-day treatment cycle.

Participant Flow:   Overall Study
Adverse Event                1 
Lack of Efficacy                30 
Withdrawal by Subject                1 

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

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   17 
[Units: Years]
Mean (Standard Deviation)
 64.9  (9.77) 
[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

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

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

Responsible Party: Millennium Pharmaceuticals, Inc. Identifier: NCT01179399     History of Changes
Other Study ID Numbers: C22001
First Submitted: August 9, 2010
First Posted: August 11, 2010
Results First Submitted: October 28, 2013
Results First Posted: March 3, 2014
Last Update Posted: March 3, 2014