Cabozantinib improves overall survival in patients with hepatocellular carcinoma compared with placebo
ID
Bron
Verkorte titel
Aandoening
Hepatocellular Carcinoma
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Overall survival
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Cabozantinib improves overall survival in patients with hepatocellular carcinoma compared with placebo
Onderzoeksopzet
Up to 38 months
Onderzoeksproduct en/of interventie
Cabozantinib
Algemeen / deelnemers
Exelixis
[default]
USA
1-855-292-3935
medinfo@exelixis.com
Wetenschappers
Exelixis
[default]
USA
1-855-292-3935
medinfo@exelixis.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6180 |
| NTR-old | NTR6335 |
| Ander register | XL184-309 : NCT01908426 |