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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00828594
First received: January 9, 2009
Last updated: April 9, 2013
Last verified: April 2013

January 9, 2009
April 9, 2013
December 2008
June 2011   (final data collection date for primary outcome measure)
  • Maximum tolerated dose of combination RAD001+sorafenib [ Time Frame: Until maximum tolerated dose is determined ] [ Designated as safety issue: Yes ]
  • Time to disease progression assessed when 60 events have been observed [ Time Frame: Until number of events are reached ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00828594 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Tumor response [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Overall tumor response (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
  • Progression Free Survivor, Overall Survivor (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
  • Biomarkers effect of treatment on soluble markers of angiogenesis and apoptosis (phase 2) [ Time Frame: Estimate of 1 year for each patient - Until number of events reached and final analysis ] [ Designated as safety issue: Yes ]
  • Pharmokinetics of RAD001 at pre-dose and 1 hour and 2 hours post-dose [ Time Frame: Estimate of 1 year for each patient - Until all patients have disease progression or leave study due to intolerable toxicity ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
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 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

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatocellular Carcinoma
  • Drug: RAD001
  • Drug: RAD001, sorafenib
Experimental: Phase 1: RAD001 plus sorafenib
Interventions:
  • Drug: RAD001
  • Drug: RAD001, sorafenib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
June 2011
June 2011   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Korea, Republic of,   Netherlands,   Spain,   Taiwan
 
NCT00828594
CRAD001O2101
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP