NCT01605227

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,028 (actual)
• Sponsor: Exelixis · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Castration Resistant Prostate Cancer
• Pain
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	cabozantinib	Tablets taken orally once-daily
DRUG	prednisone	Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-09-01
• Completion: 2015-03-01
• First posted: 2012-05-24
• Last updated: 2018-03-14
• Results posted: 2018-03-14

Locations

264 sites across 14 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Puerto Rico, Spain, Sweden, United Kingdom