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
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Hepatocellular Carcinoma
Both
Hepatocellular Carcinoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of combination RAD001+sorafenib
Outcome Time Frame:
Until maximum tolerated dose is determined
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001O2101
NCT ID:
NCT00828594
Start Date:
December 2008
Completion Date:
June 2011
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular carcinoma
- dose-finding study
- randomized trial
- medical treatment
- RAD001
- sorafenib
- Advanced hepatocellular cancer (HCC)
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|---|
| City of Hope Medical Center | Duarte, California 91010 |
| Duke University | Durham, North Carolina 27710 |
| UCLA Department of Medicine | Los Angeles, California 90005 |
