BKM120 in Metastatic Castration-resistant Prostate Cancer

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: NCT01385293
Recruitment Status : Terminated (The trial was stopped at the first stage due to futility)
First Posted : June 30, 2011
Results First Posted : April 7, 2017
Last Update Posted : May 19, 2017
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Andrew J. Armstrong, MD, Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Prostate Cancer
Metastatic (Spread to Other Areas of the Body)
Intervention: Drug: BKM120

  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
BKM 120 BKM120 at 100mg orally daily

Participant Flow:   Overall Study
    BKM 120

  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
BKM 120 BKM120 at 100mg orally daily

Baseline Measures
   BKM 120 
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Median (Full Range)
 (48 to 94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      0   0.0% 
Male      30 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
American Indian or Alaska Native      1   3.3% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      1   3.3% 
Black or African American      2   6.7% 
White      26  86.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 

  Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Prostate Cancer Working Group 2 (PCWG2) Criteria or Based on the Onset of a Skeletal Related Event.   [ Time Frame: 5 years ]

2.  Secondary:   Radiologic Response   [ Time Frame: 2 years ]

3.  Secondary:   Number of Participants With Adverse Events as a Measure of Safety and Tolerability   [ Time Frame: Up to 28 days post last study drug dose. This is the follow-up safety visit. ]

4.  Secondary:   Prostate Specific Antigen (PSA) Response   [ Time Frame: 2 years ]

5.  Secondary:   Overall Survival of Participants.   [ Time Frame: 5 years ]

6.  Secondary:   Change in Circulating Tumor Cell (CTC) Levels From Baseline   [ Time Frame: 2 years ]

7.  Secondary:   Time to New Metastatic Disease From the Baseline Visit   [ Time Frame: 5 years ]

  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Andrew J. Armstrong, MD ScM FACP
Organization: Duke University
phone: 919 668 4667

Responsible Party: Andrew J. Armstrong, MD, Duke University Identifier: NCT01385293     History of Changes
Other Study ID Numbers: Pro00027410
First Submitted: June 28, 2011
First Posted: June 30, 2011
Results First Submitted: February 22, 2017
Results First Posted: April 7, 2017
Last Update Posted: May 19, 2017