Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
This study will evaluate the efficacy and safety of everolimus treatment of patients with advanced NSCLC. The rationale for investigating everolimus in advanced NSCLC previously treated with chemotherapy or chemotherapy plus EGFR inhibitors, like gefitinib or erlotinib, is based on following:
- The medical need for the better therapy for advanced NSCLC and limited efficacy of the currently available therapy in advanced NSCLC.
- Postulated association of relevant cell-signaling pathways targeted by everolimus with different aspects of oncogenesis, disease progression, and response/resistance to treatment.
- Effectiveness of everolimus and rapamycin in preclinical models of lung cancer
- Early reports of clinical responses to monotherapy with mTOR inhibitors in advanced NSCLC.
There is evidence that an enhanced PI3K/Akt/mTOR pathway, which is inhibited by everolimus, may be one of the key changes accounting for different aspects of oncogenesis, disease progression, and response/resistance to NSCLC cancer treatment. The use of the mTOR inhibitor everolimus in treatment of advanced NSCLC would be a novel therapeutic approach that proposes to logically manipulate the cell's regulatory pathways to enable control of tumor growth.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Open Label, Non-randomized, Phase 2 Study Investigating the Effect of RAD001 Monotherapy in Patients With Advanced NSCLC Previously Treated With Either Chemotherapy Only or With Chemotherapy and EGFR Inhibitor(s)|
- Clinical efficacy based on the evaluation of objective tumor response rate (RR) [ Time Frame: until progressive disease or unacceptable toxicity. ]
- To assess safety of RAD001 monotherapy [ Time Frame: as long as patients are in the study ]
- To assess additional clinical efficacy of RAD001 [ Time Frame: as long as patients are in the study ]
- To assess the steady state levels of RAD001 in blood [ Time Frame: as long as patients are in the study ]
- To investigate potential molecular markers predictive of clinical effect [ Time Frame: as long as patients are in the study ]
|Study Start Date:||July 2005|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Experimental: previously treated with chemotherapy only
patients previously treated with chemotherapy only (at most 2 prior regimens one of which must have been platinum-based) and no EGFRI
Other Name: Everolimus
Experimental: previously treated with chemotherapy + small
patients previously treated with chemotherapy (at most 2 prior regimens one of which must have been platinum-based) and with one small molecule EGFRI
Other Name: Everolimus
Please refer to this study by its ClinicalTrials.gov identifier: NCT00124280
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|United States, Texas|
|MD Anderson Cancer Center, Department of Thoracic /Head and Neck Medical Oncology|
|Houston, Texas, United States, 77030|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceutcals|