NCT00828594

Brief 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_1 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2008

Geographic Reach
5 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

2.5 years

First QC Date

January 9, 2009

Last Update Submit

April 9, 2013

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomadose-finding studyrandomized trialmedical treatmentRAD001sorafenibAdvanced hepatocellular cancer (HCC)

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose of combination RAD001+sorafenib

    Until maximum tolerated dose is determined

  • Time to disease progression assessed when 60 events have been observed

    Until number of events are reached

Secondary Outcomes (9)

  • 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

  • Tumor response

    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

    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)

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

  • Progression Free Survivor, Overall Survivor (phase 2)

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

  • +4 more secondary outcomes

Study Arms (1)

Phase 1: RAD001 plus sorafenib

EXPERIMENTAL
Drug: RAD001Drug: RAD001, sorafenib

Interventions

RAD001DRUG
Phase 1: RAD001 plus sorafenib
RAD001, sorafenibDRUG
Phase 1: RAD001 plus sorafenib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

UCLA Department of Medicine

Los Angeles, California, 90005, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Novartis Investigative Site

Amsterdam, Netherlands

Location

Novartis Investigative Site

Seoul, South Korea

Location

Novartis Investigative Site

Barcelona, Spain

Location

Novartis Invstigative Site

Madrid, Spain

Location

Novartis Investigative Site

Tainan, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

EverolimusSorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic ChemicalsPhenylurea CompoundsUreaAmidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 26, 2009

Study Start

December 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

ES(2)KR(1)US(3)NL(1)TW(1)