Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients
NCT ID: NCT00466466
Last Updated: 2020-12-21
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
20 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Daily dosing RAD001
Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
Weekly dosing RAD001
Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
Interventions
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Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
* Adequate bone marrow, liver and renal function
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
* Symptomatic or uncontrolled brain metastases
* Other cancers within the past 5 years
* Pregnant or breastfeeding women
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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Highlands Oncology Group
Fayetteville, Arkansas, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Dana Faber Cancer Institute
Boston, Massachusetts, United States
MD Anderson Cancer Center
Houston, Texas, United States
Cancer Therapy and Research Center at UTHSCSA
San Antonio, Texas, United States
Novartis Investigative Site
Paris, , France
Countries
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Related Links
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Results for CRAD001C2116 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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CRAD001C2116
Identifier Type: -
Identifier Source: org_study_id