Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel in Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01845792|
Recruitment Status : Terminated (Low accrual)
First Posted : May 3, 2013
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Cabazitaxel with Abiraterone Acetate Drug: Cabazitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Abiraterone Acetate and Prednisone in Combination With Cabazitaxel, Compared to Cabazitaxel Alone, in Patients With Metastatic Castrate Resistant Prostate Cancer.|
|Actual Study Start Date :||July 2013|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Experimental: Cabazitaxel with Abiraterone Acetate
Cabazitaxel administered as a single intravenous dose every 3 weeks, in combination with abiraterone acetate and prednisone taken daily.
Drug: Cabazitaxel with Abiraterone Acetate
Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.
Active Comparator: Cabazitaxel Alone
Cabazitaxel administered as a single intravenous dose every 3 weeks
Cabazitaxel intravenously every 3 weeks
Other Name: Jevtana
- Progression-Free Survival [ Time Frame: 3 months ]Progression-free survival at 3 months.
- PSA Response [ Time Frame: 2 years ]Prostate specific antigen (PSA) decline by 50% or more from baseline.
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): NCT01845792
|United States, Colorado|
|University of Colorado Cancer Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Elaine Lam, MD||University of Colorado, Denver|