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

April 9, 2013 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Invstigative Site
  • Taiwan
      • Tainan, Taiwan
        • Novartis Investigative Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
      • Los Angeles, California, United States, 90005
        • UCLA Department of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Phase 1: RAD001 plus sorafenib
Drug: RAD001
Drug: RAD001, sorafenib

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Tumor response
Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
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
Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
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)
Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis
Estimate of 1 year for each patient - Until number of events reached and final analysis
Progression Free Survivor, Overall Survivor (phase 2)
Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis
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)
Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis
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)
Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis
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)
Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis
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
Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity
Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (ESTIMATE)

January 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 9, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001O2101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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