search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)


- candidate number26961
- NTR NumberNTR6335
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-apr-2017
- Secondary IDsNCT01908426 XL184-309
- Public TitleStudy of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib (CELESTIAL)
- Scientific TitleA Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
- ACRONYMCELESTIAL
- hypothesisCabozantinib improves overall survival in patients with hepatocellular carcinoma compared with placebo
- Healt Condition(s) or Problem(s) studiedHepatocellular carcinoma
- Inclusion criteriao 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 criteriao 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-jul-2013
- planned closingdate31-dec-2017
- Target number of participants760
- InterventionsCabozantinib
- Primary outcomeOverall survival
- Secondary outcomeProgression-free survival, objective response rate
- TimepointsUp to 38 months
- Trial web sitehttp://www.celestialclinicaltrial.com/
- status[default]
- CONTACT FOR PUBLIC QUERIES Exelixis
- CONTACT for SCIENTIFIC QUERIES Exelixis
- Sponsor/Initiator Exelixis
- Funding
(Source(s) of Monetary or Material Support)
Exelixis
- Publications
- Brief summaryThis 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.
- Main changes (audit trail)
- RECORD3-apr-2017 - 28-mei-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl