Study of Cabozantinib (XL184) Versus Prednisone in Men With Metastatic Castration-resistant Prostate Cancer Previously Treated With Docetaxel and Abiraterone or MDV3100 (COMET-1)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Exelixis

ClinicalTrials.gov Identifier:

NCT01605227

First received: May 22, 2012

Last updated: February 23, 2015

Last verified: February 2015

History of Changes

Tracking Information
First Received Date ^ICMJE	May 22, 2012
Last Updated Date	February 23, 2015
Start Date ^ICMJE	June 2012
Primary Completion Date	September 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 23, 2012)	Overall survival [ Time Frame: Through 21 months after study start ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01605227 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 23, 2012)	Bone scan response [ Time Frame: End of Week 12 ] [ Designated as safety issue: No ] Bone scans will be evaluated by an independent radiology facility for response
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms
Intervention ^ICMJE	Drug: cabozantinib Tablets taken orally once-daily Other Name: XL184 Drug: prednisone Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
Study Arm (s)	Experimental: cabozantinib Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules. Intervention: Drug: cabozantinib Active Comparator: prednisone Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib. Intervention: Drug: prednisone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	1028
Estimated Completion Date	March 2015
Primary Completion Date	September 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Histological or cytological diagnosis of castration resistant prostate cancer (serum testosterone less than 50 ng/dL). Evidence of bone metastasis related to prostate cancer on bone scans. Received prior docetaxel (minimum cumulative dose of 225 mg/m2) and either abiraterone or MDV3100 treatment and has evidence of prostate cancer progression on each agent independently. Maintenance of LHRH agonist or antagonist unless treated with orchiectomy. Recovered from toxicities related to any prior treatments, unless the toxicities are clinically non significant or easily manageable. Adequate organ and marrow function. Capable of understanding and complying with the protocol requirements and signed the informed consent form. Sexually active fertile patients and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the course of the study and for 4 months after the last dose of study treatment. Exclusion Criteria: Prior treatment with cabozantinib. Treatment with docetaxel, abiraterone, or MDV3100 in the last 2 weeks; or with any other type of cytotoxic or investigational anticancer agent in the last 2 weeks. Radiation within 4 weeks (excluded if to mediastinum) or radionuclide treatment within 6 weeks of randomization. Known brain metastases or cranial epidural disease. Requires concomitant treatment, in therapeutic doses, with anticoagulants. Requires chronic concomitant treatment of strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort). Uncontrolled, significant intercurrent illness including, but not limited to, cardiovascular disorders, gastrointestinal disorders, active infections, non-healing wounds, recent surgery. Clinically significant hematemesis or hemoptysis, or other signs indicative of pulmonary hemorrhage in the last 3 months, or history of other significant bleeding in the past 6 months. Cavitating pulmonary lesion(s) or a lesion invading or encasing a major blood vessel. QTcF > 500 ms within 7 days of randomization. Unable to swallow capsules or tablets. Previously-identified allergy or hypersensitivity to components of the study treatment formulations. Another diagnosis of malignancy requiring systemic treatment within 2 years of randomization.
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Puerto Rico, Spain, Sweden, United Kingdom
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01605227
Other Study ID Numbers ^ICMJE	XL184-307, 2012-001834-33
Has Data Monitoring Committee	Yes
Responsible Party	Exelixis
Study Sponsor ^ICMJE	Exelixis
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Exelixis
Verification Date	February 2015
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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