1 von 6 14.01.2014 09:11 A service of the U.S. National Institutes of Health Trial record 1 of 1 for: 2012-001834-33 Previous Study Return to List Next Study 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: Exelixis Information provided by (Responsible Party): Exelixis ClinicalTrials.gov Identifier: NCT01605227 First received: May 22, 2012 Last updated: September 26, 2013 Last verified: September 2013 History of Changes Full Text View Tabular View No Study Results Posted Disclaimer How to Read a Study Record Purpose This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castrationresistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100. Condition Intervention Phase Prostate Cancer Castration Resistant Prostate Cancer Drug: cabozantinib Drug: prednisone Phase 3
Pain Prostatic Neoplasms Study Type: Study Design: Official Title: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) Versus Prednisone in Metastatic Castrationresistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100 Resource links provided by NLM: MedlinePlus related topics: Cancer Prostate Cancer Steroids Drug Information available for: Prednisone Docetaxel Cabozantinib U.S. FDA Resources Further study details as provided by Exelixis: Primary Outcome Measures: Overall survival [ Time Frame: Through 21 months after study start ] [ Designated as safety issue: No ] Secondary Outcome Measures: 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 Estimated Enrollment: 960 Study Start Date: June 2012 2 von 6 14.01.2014 09:11
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure) Arms Experimental: cabozantinib Assigned Interventions Drug: cabozantinib Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules. Active Comparator: prednisone Subjects randomized to the prednisone arm will also receive placebo-matched 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. Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: 18 Years and older Male No Criteria 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 3 months after the last dose of study treatment. 3 von 6 14.01.2014 09:11
4 von 6 14.01.2014 09:11 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. Liver or brain metastases or cranial epidural disease. Requires concomitant treatment, in therapeutic doses, with anticoagulants antiplatelet agents. 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 in the last 5 years. Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01605227 Show 264 Study Locations Sponsors and Collaborators Exelixis More Information No publications provided
Responsible Party: Exelixis ClinicalTrials.gov Identifier: NCT01605227 History of Changes Other Study ID Numbers: XL184-307, 2012-001834-33 Study First Received: May 22, 2012 Last Updated: September 26, 2013 Health Authority: United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration Austria : Federal Ministry for Labour, Health, and Social Affairs Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada France: Agence Nationale de Sécurité du Médicament et des produits de santé Germany: Federal Institute for Drugs and Medical Devices Ireland: Irish Medicines Board Italy: Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Spain: Agencia Española de Medicamentos y Productos Sanitarios Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Keywords provided by Exelixis: prostate cancer castration resistant prostate cancer bone pain CRPC Additional relevant MeSH terms: Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Prednisone Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses 5 von 6 14.01.2014 09:11
6 von 6 14.01.2014 09:11 Docetaxel Anti-Inflammatory Agents ClinicalTrials.gov processed this record on January 12, 2014