BKM120 in Metastatic Castration-resistant Prostate Cancer
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Metastatic (Spread to Other Areas of the Body)||Drug: BKM120||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of BKM120 in Men With Metastatic Castration-Resistant Prostate Cancer|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Study arm
BKM120 at 100mg orally daily
BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily
Other Name: BKM-120
- 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 ]
Time in months from the start of study treatment to the date of first progression or death due to any cause. Progression was determined either radiographically using a composite of the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 2 (PCWG2) criteria or clinically as judged from a skeletal-related event, need for change in therapy, or clinical deterioration. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve.
Response and progression are evaluated using a combination of Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Radiologic Response [ Time Frame: 2 years ]The number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Response and progression is evaluated using a combination of the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) and the guidelines for prostate cancer endpoints developed by the Prostate Cancer Clinical Trials Working Group (PCWG2). Per RECIST, progression is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- 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. ]Number of patients experiencing grade 3-5 adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- Prostate Specific Antigen (PSA) Response [ Time Frame: 2 years ]The number of patients with a 30% and 50% decrease in PSA from baseline.
- Overall Survival of Participants. [ Time Frame: 5 years ]Time in months from the start of study treatment to date of death due to any cause. Patients alive as of the last follow-up had OS censored at the last follow-up date. Median OS was estimated using a Kaplan-Meier curve.
- Change in Circulating Tumor Cell (CTC) Levels From Baseline [ Time Frame: 2 years ]The number of patients with a baseline CTC level of at least 5 who achieved a CTC level of less than 5 during the study.
- Time to New Metastatic Disease From the Baseline Visit [ Time Frame: 5 years ]Time in days from the start of study treatment to time of new metastatic disease. Time to new metastatic disease is, defined from the date of first study agent administration to the onset of a new evaluable site of disease as per PCWG2 and RECIST 1.1 guidelines, excluding the primary site and all sites documented at baseline will be assessed. Only those patients that experienced a new lesion per this definition are included.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01385293
|United States, North Carolina|
|Duke Cancer Institute|
|Durham, North Carolina, United States, 27710|
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Andrew Armstrong, MD, ScM||Duke Cancer Institute|