Status:

TERMINATED

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

Lead Sponsor:

Novartis Pharmaceuticals

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

December 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2011

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT00828594

Start Date

December 1 2008

End Date

June 1 2011

Last Update

April 11 2013

Active Locations (8)

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Page 1 of 2 (8 locations)

1

City of Hope Medical Center

Duarte, California, United States, 91010

2

UCLA Department of Medicine

Los Angeles, California, United States, 90005

3

Duke University

Durham, North Carolina, United States, 27710

4

Novartis Investigative Site

Amsterdam, Netherlands