Safety of Everolimus and Pemetrexed in Lung Cancer Patients
Primary Purpose
Non Small Cell Lung Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Everolimus
Pemetrexed
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed
Eligibility Criteria
Inclusion criteria:
- Lung cancer
- 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:
- History of another primary malignancy in the last 5 years
- 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
Other protocol-defined inclusion/exclusion criteria may apply
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
everolimus + Pemetrexed - daily
everolimus + Pemetrexed - weekly
Arm Description
Daily treatment
Weekly treatment
Outcomes
Primary Outcome Measures
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Secondary Outcome Measures
Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)
Full Information
NCT ID
NCT00434174
First Posted
February 9, 2007
Last Updated
December 17, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00434174
Brief Title
Safety of Everolimus and Pemetrexed in Lung Cancer Patients
Official Title
A Phase I Study Investigating the Combination of Everolimus With Pemetrexed in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Previously Treated With Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will evaluate the safety of everolimus in combination with pemetrexed when used as treatment in patients with non small cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
Keywords
Lung cancer, Non small cell lung cancer, NSCLC, RAD001, Everolimus, Afinitor, Pemetrexed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
everolimus + Pemetrexed - daily
Arm Type
Experimental
Arm Description
Daily treatment
Arm Title
everolimus + Pemetrexed - weekly
Arm Type
Experimental
Arm Description
Weekly treatment
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
RAD001, Affinitor
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
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
Primary Outcome Measure Information:
Title
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Time Frame
Over 18 weeks of combination treatment
Secondary Outcome Measure Information:
Title
Assess the ability to deliver the standard pemetrexed treatment (relative dose intensity) Assess the pharmacokinetics of everolimus and chemotherapy Evaluate the effect of therapy (RECIST)
Time Frame
Over 18 weeks of combination treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Lung cancer
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:
History of another primary malignancy in the last 5 years
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
Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigative Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50924
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=4423
Description
Results for CRAD001C2112 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Safety of Everolimus and Pemetrexed in Lung Cancer Patients
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