Hepatocellular Carcinoma
Conditions
Interventions
Cabozantinib
Sponsors
Exelixis
Eligibility
Inclusion criteria
Inclusion criteria: o Histological or cytological diagnosis of hepatocellular carcinoma o The subject has disease that is not amenable to a curative treatment approach o Received prior sorafenib o Progression following at least 1 prior systemic treatment for hepatocellular carcinoma o Recovery from adverse events patient may have experienced from prior therapies o ECOG performance status of 0 or 1 o Adequate hematologic and renal function o Child-Pugh Score of A
Exclusion criteria
Exclusion criteria: o Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma o Receipt of more than 2 prior systemic therapies for advanced hepatocellular carcinoma o Any type of anticancer agent (including investigational) within 2 weeks before randomization o Radiation therapy within 4 weeks (2 weeks for radiation for bone metastases) or radionuclide treatment within 6 weeks of randomization o Prior cabozantinib treatment o Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization o Concomitant anticoagulation, at therapeutic doses, with anticoagulants o Subjects with untreated or incompletely treated varices with bleeding or high risk for bleeding o Moderate or severe ascites o Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, objective response rate | — |
Contacts
Public ContactExelixis
Exelixis, Inc., 210 East Grand Avenue, South San Francisco, CA 94080
Outcome results
None listed