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

Phase 1TerminatedNCT00828594

Novartis Pharmaceuticals130 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Hepatocellular Carcinoma

Interventions

RAD001DRUG

RAD001, sorafenibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

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

Outcomes

Primary Outcomes

Maximum tolerated dose of combination RAD001+sorafenib

Time frame: Until maximum tolerated dose is determined

Time to disease progression assessed when 60 events have been observed

Time frame: Until number of events are reached

Secondary Outcomes

Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events

Time frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Tumor response

Time frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis

Time frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity

Overall tumor response (phase 2)

Time frame: Estimate of 1 year for each patient - Until number of events reached and final analysis

Progression Free Survivor, Overall Survivor (phase 2)

Time frame: Estimate of 1 year for each patient - Until number of events reached and final analysis

Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2)

Time frame: Estimate of 1 year for each patient - Until number of events reached and final analysis

Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2)

Data from ClinicalTrials.gov

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