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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: RAD001; Drug: RAD001, sorafenib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00828594

CRAD001O2101

Details and patient eligibility

About

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

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

130 participants in 1 patient group

Phase 1: RAD001 plus sorafenib

Experimental group

Treatment:

Drug: RAD001, sorafenib

Drug: RAD001