Safety of Everolimus and Pemetrexed in Lung Cancer Patients
NCT ID: NCT00434174
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
48 participants
INTERVENTIONAL
2006-12-31
2010-12-31
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
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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everolimus + Pemetrexed - daily
Daily treatment
Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths.
Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.
Pemetrexed
Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
everolimus + Pemetrexed - weekly
Weekly treatment
Everolimus
RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. All proposed dose levels in this study can be given as a combination of these dose strengths.
Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.
Pemetrexed
Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
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. All proposed dose levels in this study can be given as a combination of these dose strengths.
Daily doses of 2.5, 5, 7.5 and 10 mg of RAD001 will be given alongside the standard 21-day cycle of pemetrexed.
Pemetrexed
Pemetrexed was supplied to the sites in 500 mg/m2 was administered on Day 1 of each cycle as a 10-minute continuous i.v. infusion in 100mL normal saline
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Only one prior regimen of chemotherapy for the treatment of non small cell lung cancer
* Adequate bone marrow function
* Adequate liver function
* Adequate renal function
* Negative serum pregnancy test
Exclusion Criteria
* Having recently received an investigational drug
* Having recently received major surgery of wide field radiotherapy
* Chronic treatment with immunosuppressive therapy, steroids or liver enzyme modulators
* Severe or uncontrolled medical conditions
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
Novartis
Role: STUDY_CHAIR
Novartis
Locations
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Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Hamburg, , Germany
Countries
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Related Links
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Results for CRAD001C2112 can be found on the Novartis Clinical Trial Results Website
Other Identifiers
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2006-002759-34
Identifier Type: -
Identifier Source: secondary_id
CRAD001C2112
Identifier Type: -
Identifier Source: org_study_id