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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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