We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

BKM120 in Metastatic Castration-resistant Prostate Cancer

This study has been terminated.
(The trial was stopped at the first stage due to futility)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01385293
First Posted: June 30, 2011
Last Update Posted: May 19, 2017
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Andrew J. Armstrong, MD, Duke University Medical Center
Results First Submitted: 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
  Hide Participant Flow

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
No text entered.

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
  Hide 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
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
  Hide 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
  Hide 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
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
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