Global Study Looking at the Combination of RAD001 and Sorafenib to Treat Patients With Advanced Hepatocellular Carcinoma
NCT ID: NCT00828594
Last Updated: 2013-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
130 participants
INTERVENTIONAL
2008-12-31
2011-06-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1: RAD001 plus sorafenib
RAD001
RAD001, sorafenib
Interventions
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RAD001
RAD001, sorafenib
Eligibility Criteria
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Inclusion Criteria
* No previous systemic therapy for liver cancer
* Measurable disease on CT or MRI
* ECOG 1 or less
* Child-Pugh A
Exclusion Criteria
* Known history of HIV seropositivity
* Any severe and/or uncontrolled medical conditions including
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Barcelona, , Spain
Novartis Invstigative Site
Madrid, , Spain
Novartis Investigative Site
Tainan City, , Taiwan
Countries
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Other Identifiers
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CRAD001O2101
Identifier Type: -
Identifier Source: org_study_id
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