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 currently recruiting participants.
Verified May 2013 by Exelixis
Information provided by (Responsible Party):
First received: May 22, 2012
Last updated: May 2, 2013
Last verified: May 2013
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.
Castration Resistant Prostate Cancer
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 Castration-resistant Prostate Cancer Patients Who Have Received Prior Docetaxel and Prior Abiraterone or MDV3100
Primary Outcome Measures:
- Overall survival [ Time Frame: Through 21 months after study start ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||March 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01605227
|Contact: Exelixis Contact Line
||1-888- EXELIXIS (888-393-5494)
|Contact: Non-Toll Free Contact Line (international callers)
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 22, 2012
||May 2, 2013
||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: L’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:
castration resistant prostate cancer
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 22, 2013
Genital Neoplasms, Male
Neoplasms by Site
Genital Diseases, Male
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal