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

Stopped early · Phase 1

Conditions studied: Hepatocellular Carcinoma

In brief

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

Key facts

Study ID

NCT00828594

Run by

Novartis Pharmaceuticals

People needed

130

Starts

2008-12-01

Expected to finish

2011-06-01

Last updated by the study team

2013-04-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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