Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients
NCT ID: NCT00457119
Last Updated: 2013-02-12
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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COMPLETED
PHASE1
69 participants
INTERVENTIONAL
2007-02-28
2009-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Step 1 Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel
RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Step 1, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel
RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Step 2, Arm 1
5mg/day RAD001 + Carboplatin + Paclitaxel + Bevacizumab
RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Step 2, Arm 2
30mg/week RAD001 + Carboplatin + Paclitaxel + Bevacizumab
RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Interventions
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RAD001
5mg oral tablets of RAD001 - for the 5mg/daily arm, 10mg oral tablets x 3 of RAD001 - for the 30mg/weekly arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
* Ability to perform normal daily functions
Exclusion Criteria
* Prior treatment with chemotherapy for advanced lung cancer
* Prior treatment with mTOR inhibitors
* Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
* Known sensitivity to platinum compounds, taxanes or bevacizumab
* Other cancers within the past 5 years
23 Years
76 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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Georgetown University/Lombardi Cancer Center StudyCoordinator:CRAD001C2114
Washington D.C., District of Columbia, United States
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center
New Orleans, Louisiana, United States
U of TX Southwestern Medical Center - SimmonsCompCancerCtr Clinical Research Office
Dallas, Texas, United States
MD Anderson Cancer Center/University of Texas Thoractic Head/Neck Med. Onc.
Houston, Texas, United States
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Heidelberg, Victoria, Australia
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Countries
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Other Identifiers
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2006-002760-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001C2114
Identifier Type: -
Identifier Source: org_study_id
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