A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100
Study Status
Open to Enrollment
Study Description
This clinical trial is for men with metastatic castration-resistant prostate cancer (CRPC) whose cancer has gotten worse after other treatments. The study is evaluating an experimental drug called cabozantinib (XL184).
The purpose of the study is to determine if cabozantinib is effective in prolonging survival compared to the drug prednisone. The study will also evaluate the safety of cabozantinib and how well people with advanced prostate cancer tolerate the drug. In an ongoing study, cabozantinib treatment has resulted in high rates of pain relief and has shown substantial anti-tumor activity. Cabozantinib could provide a valuable new treatment option for men with CRPC who experience disease progression on or after prior therapies.
Study participants will be randomly assigned to one of two treatment groups:
Group 1: cabozantinib once daily + placebo prednisone twice daily
Group 2: Prednisone twice daily + placebo cabozantinib once daily
Participants have a 2/3 chance of receiving cabozantinib (Group 1) and a 1/3 chance of receiving prednisone (Group 2). Participants will not know which treatment they are receiving. Cabozantinib is a capsule and prednisone is a tablet, both taken by mouth.
Participants will continue to receive study treatment as long as they continue to receive clinical benefit and do not experience unacceptable side effects.
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Disease Status and/or Stage
Metastatic Castration-Resistant Prostate Cancer
Sponsor
Exelixis
Key Eligibility
- Metastatic castration-resistant prostate cancer
- Evidence of bone metastasis related to prostate cancer
- Must have received prior treatment with docetaxel and either abiraterone or MDV3100 and have had disease progression on each medication
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Renee Khan, RN
- (212) 746-1851
- [email protected]
Protocol ID
XL184-307
Healthy Volunteers
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]
