Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18 - 75
Clinical summary
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.
Conditions
This trial is treating people with Hepatocellular (Liver) Cancer
Eligibility
Inclusion
- 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
- 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.
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Exelixis
Scientific Title
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (Other ID's: XL184-309)
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