Trial Information
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
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Establish feasible dose levels/regimens of everolimus combined with pemetrexed chemotherapy through estimation of the End-of-Cycle 1 DLT rate.
Outcome Time Frame:
Over 18 weeks of combination treatment
Safety Issue:
Yes
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
CRAD001C2112
NCT ID:
NCT00434174
Start Date:
December 2006
Completion Date:
December 2010
Related Keywords:
- Non Small Cell Lung Cancer
- Lung cancer
- Non small cell lung cancer
- NSCLC
- RAD001
- Everolimus
- Afinitor
- Pemetrexed
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms