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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
Not Enrolling
Both
Hepatocellular Carcinoma

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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 CenterDuarte, California  91010
Duke UniversityDurham, North Carolina  27710
UCLA Department of MedicineLos Angeles, California  90005