Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma

Phase 1

Terminated

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: RAD001; Drug: RAD001, sorafenib

• Registration Number: NCT00828594
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Phase 1 Evaluate the safety and tolerability of RAD001 in combination with sorafenib in patients with advance hepatocellular cancer (HCC) and to determine the maximum tolerated dose (MTD)

Phase 2 To estimate the treatment effect as a measure of anti-tumor activity in terms of Time to Progression (TTP) of the combination of RAD001 plus sorafenib, at the MTD, as compared to sorafenib alone

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-23
• Study First Posted: 2009-01-26
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-09
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Advanced liver cancer
• No previous systemic therapy for liver cancer
• Measurable disease on CT or MRI
• ECOG 1 or less
• Child-Pugh A

Exclusion Criteria

• Active bleeding during the last 30 days
• Known history of HIV seropositivity
• Any severe and/or uncontrolled medical conditions including

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1: RAD001 plus sorafenib	RAD001	-
Phase 1: RAD001 plus sorafenib	RAD001, sorafenib	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of combination RAD001+sorafenib	Until maximum tolerated dose is determined
Time to disease progression assessed when 60 events have been observed	Until number of events are reached

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events	Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Tumor response	Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis	Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Overall tumor response (phase 2)	Estimate of 1 year for each patient - Until number of events reached and final analysis
Progression Free Survivor, Overall Survivor (phase 2)	Estimate of 1 year for each patient - Until number of events reached and final analysis
Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2)	Estimate of 1 year for each patient - Until number of events reached and final analysis
Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2)	Estimate of 1 year for each patient - Until number of events reached and final analysis
Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2)	Estimate of 1 year for each patient - Until number of events reached and final analysis
Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose	Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Trial Locations

Locations (5)

Novartis Invstigative Site; 🇪🇸 Madrid, Spain

Novartis Investigative Site; 🇨🇳 Tainan, Taiwan

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

UCLA Department of Medicine; 🇺🇸 Los Angeles, California, United States