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
Results First Posted : March 14, 2018
Last Update Posted : March 14, 2018
|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 :||July 2012|
|Actual Primary Completion Date :||September 2014|
|Actual 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 (OS) [ Time Frame: OS was measured from the time of randomization until 614 events, approximately 24 months after study start ]The primary analysis of OS is defined as the time from randomization to death due to any cause. Participants that had not died or were permanently lost to follow-up were censored at the last known date alive. Median OS was calculated using Kaplan-Meier estimates. Analysis for OS was performed after 614 events had occurred.
- Bone Scan Response (BSR) [ Time Frame: BSR was measured at the end of Week 12 as determined by the IRF ]BSR is defined as >=30% reduction in the bone scan lesion area (BSLA) compared with baseline. Confirmation of bone scan was not required for response or progression. Bone scans were evaluated by an independent radiology facility (IRF) for response.
- Progression-free Survival (PFS) [ Time Frame: Duration of PFS was defined as time from the date of randomization to earlier of date of radiographic progression (bone/andor soft tissue) according to the investigator's assessment or death, assessed for up to approximately 24 months ]The exploratory analysis of PFS is the time from randomization to date of first documented radiographic progression (bone and/or soft tissue) according to the investigator's assessment or death. PFS was defined per mRECIST 1.1 and included evaluation of measurable, nonmeasurable, target and nontarget lesions. A Kaplan-Meier analysis was performed to estimate the median duration.
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