Trial record 1 of 1 for:
MDV3100 COMET
Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)
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ClinicalTrials.gov Identifier: NCT01605227 |
Recruitment Status
:
Completed
First Posted
: May 24, 2012
Results First Posted
: March 14, 2018
Last Update Posted
: March 14, 2018
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Sponsor:
Exelixis
Information provided by (Responsible Party):
Exelixis
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Tracking Information | |||
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First Submitted Date ICMJE | May 22, 2012 | ||
First Posted Date ICMJE | May 24, 2012 | ||
Results First Submitted Date | May 23, 2017 | ||
Results First Posted Date | March 14, 2018 | ||
Last Update Posted Date | March 14, 2018 | ||
Study Start Date ICMJE | July 2012 | ||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: Through 21 months after study start ] | ||
Change History | Complete list of historical versions of study NCT01605227 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
Bone scan response [ Time Frame: End of Week 12 ] Bone scans will be evaluated by an independent radiology facility for response
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Current Other Outcome Measures ICMJE |
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.
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Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 | ||
Official Title ICMJE | 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 | ||
Brief Summary | This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
1028 | ||
Original Estimated Enrollment ICMJE |
960 | ||
Actual Study Completion Date | March 2015 | ||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Puerto Rico, Spain, Sweden, United Kingdom, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01605227 | ||
Other Study ID Numbers ICMJE | XL184-307 2012-001834-33 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Exelixis | ||
Study Sponsor ICMJE | Exelixis | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Exelixis | ||
Verification Date | February 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |