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 : Completed
First Posted : July 25, 2013
Results First Posted : March 1, 2019
Last Update Posted : May 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Cabozantinib tablets Drug: Placebo tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||707 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 :||September 26, 2013|
|Actual Primary Completion Date :||October 16, 2017|
|Actual Study Completion Date :||January 12, 2021|
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 45 months ]The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
- Progression-Free Survival (PFS) [ Time Frame: Up to 45 months ]Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.
- Objective Response Rate (ORR) [ Time Frame: ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 months) ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + 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