Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)
|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.|
|ClinicalTrials.gov Identifier: NCT01605227|
Recruitment Status : Completed
First Posted : May 24, 2012
Last Update Posted : April 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms||Drug: cabozantinib Drug: prednisone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1028 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100|
|Study Start Date :||June 2012|
|Primary Completion Date :||September 2014|
|Study Completion Date :||March 2015|
Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules.
Tablets taken orally once-daily
Other Name: XL184
Active Comparator: prednisone
Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.
Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
- Overall survival [ Time Frame: Through 21 months after study start ]
- Bone scan response [ Time Frame: End of Week 12 ]Bone scans will be evaluated by an independent radiology facility for response
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): NCT01605227
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