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BKM120 in Metastatic Castration-resistant Prostate Cancer

This study has been terminated.
(The trial was stopped at the first stage due to futility)
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Andrew J. Armstrong, MD, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01385293
First received: June 28, 2011
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: February 22, 2017  
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
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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
BKM 120 BKM120 at 100mg orally daily

Participant Flow:   Overall Study
    BKM 120
STARTED   30 
COMPLETED   30 
NOT COMPLETED   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
BKM 120 BKM120 at 100mg orally daily

Baseline Measures
   BKM 120 
Overall Participants Analyzed 
[Units: Participants]
 30 
Age 
[Units: Years]
Median (Full Range)
 67 
 (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
  Show All 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
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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:  
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
e-mail: andrew.armstrong@duke.edu



Responsible Party: Andrew J. Armstrong, MD, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01385293     History of Changes
Other Study ID Numbers: Pro00027410
Study First Received: June 28, 2011
Results First Received: February 22, 2017
Last Updated: April 14, 2017