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

Primary Purpose

Hepatocellular Carcinoma

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

RAD001

RAD001, sorafenib

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, dose-finding study, randomized trial, medical treatment, RAD001, sorafenib, Advanced hepatocellular cancer (HCC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 1: RAD001 plus sorafenib

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose of combination RAD001+sorafenib

Time to disease progression assessed when 60 events have been observed

Secondary Outcome Measures

Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events

Tumor response

Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis

Overall tumor response (phase 2)

Progression Free Survivor, Overall Survivor (phase 2)

Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2)

Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2)

Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2)

Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose

Full Information

NCT ID

NCT00828594

First Posted

January 9, 2009

Last Updated

April 9, 2013

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00828594

Brief Title

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

Official Title

A Phase 1 Open Label/ Phase 2 Randomized, Double-blind, Multicenter Study Investigating the Combination of RAD001 and Sorafenib (Nexavar®) in Patients With Advanced Hepatocellular Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Terminated

Study Start Date

December 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma, dose-finding study, randomized trial, medical treatment, RAD001, sorafenib, Advanced hepatocellular cancer (HCC)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

130 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1: RAD001 plus sorafenib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

RAD001

Intervention Type

Drug

Intervention Name(s)

RAD001, sorafenib

Primary Outcome Measure Information:

Title

Maximum tolerated dose of combination RAD001+sorafenib

Time Frame

Until maximum tolerated dose is determined

Title

Time to disease progression assessed when 60 events have been observed

Time Frame

Until number of events are reached

Secondary Outcome Measure Information:

Title

Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events

Time Frame

Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Title

Tumor response

Time Frame

Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Title

Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis

Time Frame

Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Title

Overall tumor response (phase 2)

Time Frame