CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,028 enrolled
Drug / intervention
cabozantinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01605227
NCT01605227Phase 3Completed

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

Exelixis·interventional·Posted May 24, 2012·Updated Mar 14, 2018

In Brief

A Phase 3 clinical trial evaluating cabozantinib and prednisone for Prostate Cancer and 3 related conditions. Completed, enrolled 1,028 participants across 264 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Ireland, Italy, Netherlands, Puerto Rico, Spain, Sweden, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 24, 2012
Enrollment StartJul 1, 2012
Primary CompletionSep 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 14.1 years ago

Interventions

cabozantinibdrug

Tablets taken orally once-daily

prednisonedrug

Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.