A Phase I open label/ Phase II randomized, double-blind, multicenter study investigating the combination of RAD001 and sorafenib (Nexavar®) in patients with advanced hepatocellular carcinoma
- Conditions
- Hepatocellular carcinomaliver cancer10019815
- Registration Number
- NL-OMON32745
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
- Male or female patients * 18 years old with ability to take oral drugs
- Diagnosis of advanced HCC according to the AASLD Guidelines (Bruix and Sherman 2005)
- HCC stage B or C according to the Barcelona Clinic Liver Cancer (BCLC)
- No previous systemic therapy for HCC
- Measurable disease as per RECIST, that is, at least one lesion that has not been previously treated with local therapy. Previously treated lesions will be considered *non target* lesion. Local therapy must be completed at least four weeks prior to baseline scans.
- Patients with ECOG performance status of 0 or 1
- Cirrhotic status of current Child-Pugh class A only (5-6 points) with no encephalopathy. Child-Pugh status should be calculated based on clinical findings and laboratory results during screening period.
- Patients currently receiving any anti cancer therapy or who have received any local anti cancer therapy *4 weeks prior to study treatment start
- Active bleeding during the last 30 days
- Known previous/current malignancy * 3 years except for cervical carcinoma in situ, basal cell carcinoma, superficial bladder carcinoma
- Known central nervous system disease
- Known history of HIV seropositivity (HIV testing is not mandatory)
- Any severe and/or uncontrolled medical conditions.
- Patients receiving chronic treatment with any systemic immunosuppressive agent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Phase I<br /><br>Dose Limiting Toxicities (DLT) of treatment combination of RAD001 plus<br /><br>sorafenib<br /><br>Pharmacokinetic measures of systemic exposure, such as AUC, Cmax and trough<br /><br>blood levels.<br /><br>Both Phase I and II<br /><br>efficacy evaluation based on the overall response rate according to RECIST</p><br>
- Secondary Outcome Measures
Name Time Method <p>- clinical efficacy in terms of : objective response rate (ORR); disease<br /><br>control rate (DCR); progression-free survival (PFS), according to RECIST<br /><br>- safety and tolerability: rate and severity of adverse events</p><br>