Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Exelixis
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01908426
First received: July 23, 2013
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Drug: Cabozantinib (XL184)
Drug: Placebo
Phase 3

Study Type: Interventional
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:


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).


Estimated Enrollment: 760
Study Start Date: August 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184): oral cabozantinib tablet once a day
Drug: Cabozantinib (XL184)
Placebo Comparator: Placebo
Oral cabozantinib-matched placebo tablet once daily
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908426

Contacts
Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494)
Contact: Backup or International 650-837-7400

  Show 140 Study Locations
Sponsors and Collaborators
Exelixis
  More Information

No publications provided

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01908426     History of Changes
Other Study ID Numbers: XL184-309
Study First Received: July 23, 2013
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Exelixis:
cabozantinib
XL184
liver cancer
hepatocellular carcinoma
tyrosine kinase inhibitor
MET
vascular endothelial growth factor receptor 2 (VEGFR2)

Additional relevant MeSH terms:
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
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014