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 August 2014 by Exelixis
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01908426
First received: July 23, 2013
Last updated: August 11, 2014
Last verified: August 2014

July 23, 2013
August 11, 2014
August 2013
October 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01908426 on ClinicalTrials.gov Archive Site
  • 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).
Same as current
Not Provided
Not Provided
 
Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: Cabozantinib (XL184)
  • Drug: Placebo
  • Experimental: Cabozantinib (XL184)
    Cabozantinib (XL184): oral cabozantinib tablet once a day
    Intervention: Drug: Cabozantinib (XL184)
  • Placebo Comparator: Placebo
    Oral cabozantinib-matched placebo tablet once daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
760
Not Provided
October 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494)
Contact: Backup or International 650-837-7400
United States,   Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Hong Kong,   Ireland,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Singapore,   Spain,   Taiwan,   Turkey,   United Kingdom
 
NCT01908426
XL184-309
Yes
Exelixis
Exelixis
Not Provided
Not Provided
Exelixis
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP