|Recruiting||Hepatocellular Carcinoma||Phase III||
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.
- 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.
Other eligibility criteria may apply.
- 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.
Other exclusion criteria may apply.
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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