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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
Sponsor:
Information provided by (Responsible Party):
Exelixis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Cabozantinib tablets Drug: Placebo tablets Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 707 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 26, 2013
Actual Primary Completion Date : October 16, 2017
Actual Study Completion Date : January 12, 2021

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Select Inclusion Criteria:

  1. Histological or cytological diagnosis of HCC.
  2. The subject has disease that is not amenable to a curative treatment approach.
  3. Received prior sorafenib.
  4. Progression following at least 1 prior systemic treatment for HCC.
  5. Recovery to from toxicities related to any prior treatments.
  6. ECOG performance status of 0 or 1.
  7. Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
  8. Child-Pugh Score of A.
  9. Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
  10. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
  11. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

  1. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
  2. Receipt of more than 2 prior systemic therapies for advanced HCC.
  3. Any type of anticancer agent (including investigational) within 2 weeks before randomization.
  4. Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization.
  5. Prior cabozantinib treatment.
  6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
  7. Concomitant anticoagulation, at therapeutic doses, with anticoagulants.
  8. Serious illness other than cancer that would preclude safe participation in the study.
  9. Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding.
  10. Moderate or severe ascites.
  11. Pregnant or lactating females.
  12. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low-grade tumors.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Exelixis
  Study Documents (Full-Text)

Documents provided by Exelixis:
Study Protocol  [PDF] July 12, 2016
Statistical Analysis Plan  [PDF] June 8, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01908426    
Other Study ID Numbers: XL184-309
First Posted: July 25, 2013    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: May 6, 2021
Last Verified: April 2021
Keywords provided by Exelixis:
cabozantinib
XL184
liver cancer
hepatocellular carcinoma
 tyrosine kinase inhibitor
MET kinase
vascular endothelial growth factor receptor 2 (VEGFR2)
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases