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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00828594
• Other study ID #: CRAD001O2101
• Status: Terminated
• Phase: Phase 1
• First received: January 9, 2009
• Last updated: April 9, 2013
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationKorea: Food and Drug AdministrationSpain: Ethics CommitteeTaiwan: Department of HealthHong Kong: Department of HealthNetherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• RAD001

• RAD001, sorafenib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Netherlands,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of combination RAD001+sorafenib		Until maximum tolerated dose is determined	Yes
Primary	Time to disease progression assessed when 60 events have been observed		Until number of events are reached	Yes
Secondary	Safety and tolerability of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events		Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity	Yes
Secondary	Tumor response		Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity	Yes
Secondary	Biomarkers- effect of treatment on soluble markers of angiogenesis and apoptosis		Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity	Yes
Secondary	Overall tumor response (phase 2)		Estimate of 1 year for each patient - Until number of events reached and final analysis	Yes
Secondary	Progression Free Survivor, Overall Survivor (phase 2)		Estimate of 1 year for each patient - Until number of events reached and final analysis	Yes
Secondary	Safety and tolerability - of the combination of RAD001 plus sorafenib as measured by the rate and severity of adverse events (phase 2)		Estimate of 1 year for each patient - Until number of events reached and final analysis	Yes
Secondary	Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2)		Estimate of 1 year for each patient - Until number of events reached and final analysis	Yes
Secondary	Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2)		Estimate of 1 year for each patient - Until number of events reached and final analysis	Yes
Secondary	Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose		Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity	Yes