Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)
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|ClinicalTrials.gov Identifier: NCT01908426|
Recruitment Status : Active, not recruiting
First Posted : July 25, 2013
Last Update Posted : October 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Cabozantinib tablets Drug: Placebo tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||760 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2013|
|Primary Completion Date :||October 16, 2017|
|Estimated Study Completion Date :||October 2018|
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily
Drug: Cabozantinib tablets
Other Name: XL184
Placebo Comparator: Placebo
Oral cabozantinib-matched placebo tablet once daily
|Drug: Placebo tablets|
- Overall Survival (OS) [ Time Frame: Up to 38 months ]OS is defined as the time from randomization to death from any cause.
- Progression-Free Survival (PFS) [ Time Frame: Up to 38 months ]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 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908426
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