Fase I/II study: RAD001 and sorafenib combination in patients with advanced hcc.
Recruiting
- Conditions
- hepatocellular carcinomaRAD001sorafenibeverolimusLeverkankerRAD001sorafenibeverolimus
- Registration Number
- NL-OMON24345
- Lead Sponsor
- ovartis Pharma
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
1. Male or female patients ¡Ý 18 years old with ability to take oral drugs;
2. Diagnosis of advanced HCC according to the AASLD Guidelines (Bruix and Sherman 2005);
Exclusion Criteria
1. Patients currently receiving any anti cancer therapy or who have received any local anti cancer therapy ¡Ü4 weeks prior to study treatment start;
2. Active bleeding during the last 30 days;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I:<br /> <br>1. Dose Limiting Toxicities (DLT) of treatment combination of RAD001 plus sorafenib;<br /> <br>2. Pharmacokinetic measures of systemic exposure, such as AUC, Cmax and trough blood levels.<br><br /><br /><br>Both Phase I and II:<br /><br>Efficacy evaluation based on the overall response rate according to RECIST.
- Secondary Outcome Measures
Name Time Method 1. Clinical efficacy in terms of:<br /><br>A. Objective response rate (ORR);<br /><br>B. Disease control rate (DCR);<br /><br>C. Progression-free survival (PFS), according to RECIST.<br /><br>2. Safety and tolerability: rate and severity of adverse events.