Ignite Creation Date:
2024-05-06 @ 2:27 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02049047
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2013-05-27
Brief Title:
Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy
Sponsor:
Armando Santoro MD
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Phase II Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy
Status:
COMPLETED
Status Verified Date:
2022-09
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:
ONC-2010-001
Brief Summary:
Given the high expression of IGF-1R and pAKT proteins in thymoma tissues able to sensitize tumors to mTOR inhibition and the anticancer activity of the mTOR inhibitors clinical evaluation in thymoma and thymic carcinoma seems to be very interesting
Patients will receive continuous treatment with oral everolimus 10 mg once daily
Efficacy and safety profile of Everolimus will be evaluated
Patients will receive continuous treatment with oral everolimus 10 mg once daily
Efficacy and safety profile of Everolimus will be evaluated
Detailed Description:
Patients will receive continuous treatment with oral everolimus 10 mg once daily Study drug will be self-administered orally two 5 mg tablets daily in a fasting state or with a light fat-free meal Each cycle will be considered as 21 days of treatment safety was assessed every 21 days Tumor assessement will be done every two cycles Treatment should be administered until documented disease progression unacceptable toxicity or patient refusal
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