No registrations found.
ID
Source
Brief title
Health condition
Hepatocellular Carcinoma
Sponsors and support
Intervention
Outcome measures
Primary outcome
Overall survival
Secondary outcome
Progression-free survival, objective response rate
Background summary
This study is investigating a therapy called cabozantinib for the treatment of advanced hepatocellular carcinoma, the most common form of liver cancer, in adults whose disease has spread or grown after treatment with the medication sorafenib. The main purpose of the CELESTIAL trial is to determine whether cabozantinib can improve patient survival.
Study objective
Cabozantinib improves overall survival in patients with hepatocellular carcinoma compared with placebo
Study design
Up to 38 months
Intervention
Cabozantinib
Exelixis
[default]
USA
1-855-292-3935
medinfo@exelixis.com
Exelixis
[default]
USA
1-855-292-3935
medinfo@exelixis.com
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6180 |
| NTR-old | NTR6335 |
| Other | XL184-309 : NCT01908426 |