Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)
This study is currently recruiting participants.
Verified April 2014 by Exelixis
Information provided by (Responsible Party):
First received: July 23, 2013
Last updated: April 15, 2014
Last verified: April 2014
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
Drug: Cabozantinib (XL184)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Exelixis:
Primary Outcome Measures:
- Overall Survival (OS) [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]OS is defined as the time from randomization to death from any cause.
Secondary Outcome Measures:
- Progression-Free Survival (PFS) [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]Duration of PFS is defined as the time of randomization to the earlier of the following events: progressive disease or death due to any cause.
- Objective Response Rate (ORR) [ Time Frame: Up to 38 months ] [ Designated as safety issue: No ]ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment. ORR is the proportion of subjects experiencing a confirmed complete response(CR) or confirmed partial response (PR).
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184): oral cabozantinib tablet once a day
|Drug: Cabozantinib (XL184)|
Placebo Comparator: Placebo
Oral cabozantinib-matched placebo tablet once daily
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01908426
Show 129 Study Locations
|Contact: Exelixis Clinical Trials||1-888-EXELIXIS (888-393-5494)|
|Contact: Backup or International||650-837-7400|
Show 129 Study Locations
Sponsors and Collaborators