Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma (NCT01215565) | Clinical Trial Compass
TerminatedPhase 2
Study of Sunitinib in Patients With Advanced/Inoperable Fibrolamellar Carcinoma
Stopped: lack of inclusion
France4 participantsStarted 2009-10
Plain-language summary
The purpose of this study is to evaluate the antitumor activity of sunitinib in patients with advanced/inoperable fibrolamellar hepatocellular carcinoma.
Rationale: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Fibrolamellar hepatocellular carcinoma histopathologically proven
* Inoperable/advanced (Tumor recurrence inoperable or metastatic with no surgical indication).
* Available Tumor tissue for analysis(biopsy or surgical specimen)
* Performance status WHO ≤ 2.
* Adequate organ function :
* Hematology (absolute neutrophil count equal or superior to 1,5 x 10\*9/l , platelet equal or superior to 100 x 10\*9/l),
* clearance of creatinine \> 60 ml/min),
* AST/ALT ≤ 5 N, PAL ≤ 5 N, total bilirubin ≤ 2N.
Exclusion Criteria:
* Hypersensitivity to sunitinib.
* Contraindication to sunitinib, including uncontrolled hypertension, medical history of cerebrovascular accident, unstable cardiac pathology despite optimal medical therapy (myocardial infarction within the 6 months prior to study drug administration, severe/unstable angina ), active hemorrhagic syndrome or concomitant treatment with anticoagulants.
* Any severe acute or chronic co-morbid that may compromise to comply with study participation : uncontrolled infection, symptomatic congestive heart failure, liver disturbance, chronic renal failure, active gastro-duodenal ulcer (nonexhaustive list)
* Known brain metastases.
* Diagnosis of any second malignancy within the last 3 years, except for basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri
* Current treatment on another clinical trial.
* Prior treatment with an investigational agent within 4 weeks
* Patient on i.v bis…