Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124280
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2005-07-26
Brief Title:
Study Investigating the Effect of Everolimus Monotherapy in Patients With Advanced Non-small Cell Lung Cancer NSCLC
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
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 Inhibitors
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 responseresistance 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 PI3KAktmTOR pathway which is inhibited by everolimus may be one of the key changes accounting for different aspects of oncogenesis disease progression and responseresistance 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 cells regulatory pathways to enable control of tumor growth
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 responseresistance 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 PI3KAktmTOR pathway which is inhibited by everolimus may be one of the key changes accounting for different aspects of oncogenesis disease progression and responseresistance 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 cells regulatory pathways to enable control of tumor growth
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None