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

Trial Status: Complete

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.

Inclusion Criteria

  • Histological or cytological diagnosis of HCC.
  • The subject has disease that is not amenable to a curative treatment approach.
  • Received prior sorafenib.
  • Progression following at least 1 prior systemic treatment for HCC.
  • Recovery to from toxicities related to any prior treatments.
  • ECOG performance status of 0 or 1.
  • Adequate hematologic and renal function, based upon meeting protocol defined laboratory criteria within 7 days before randomization.
  • Child-Pugh Score of A.
  • Antiviral therapy per local standard of care if active hepatitis B (HBV) infection.
  • 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.
  • Female subjects of childbearing potential must not be pregnant at screening.

Exclusion Criteria

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

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Anthony El-Khoueiry
Phone: 323-865-0451
San Francisco
UCSF Medical Center-Mount Zion
Status: COMPLETED

Hawaii

Honolulu
University of Hawaii Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Manish R. Sharma
Phone: 773-834-7424

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: COMPLETED

Minnesota

Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Ghassan K. Abou-Alfa
Phone: 212-639-7202
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: COMPLETED

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Contact: William Proctor Harris
Phone: 206-616-8289
Email: wph3@uw.edu

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Exelixis Inc

  • Primary ID XL184-309
  • Secondary IDs NCI-2013-02092
  • Clinicaltrials.gov ID NCT01908426