Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy (ONC-2010-001)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Everolimus in Patients With Thymoma and Thymic Carcinoma Previously Treated With Chemotherapy|
- disease control rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD), of Everolimus monotherapy
- PFS [ Time Frame: 6 months ] [ Designated as safety issue: No ]Progression free survival (PFS) will be evaluated from the date of treatment start until the date of progression or death whichever occurs first, otherwise until the last visit date.
- Duration of Response [ Time Frame: 6 months ] [ Designated as safety issue: No ]This endpoint is assessed in patients whose best tumor response is CR or PR as the time from the date of the first documentation of confirmed objective tumor response to the date of first documentation of objective tumor progression, objective tumor recurrence, or of death due progressive disease, whichever comes first
- OS [ Time Frame: 6 months ] [ Designated as safety issue: No ]Overall Survival (OS) will be evaluated from the date of treatment start until the date of death or last contact for patients alive at the end of the study.
- FDG-PET imaging relations [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging.
- safety profile [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Overall safety profile, evaluated on the basis of laboratory and clinical safety parameters
- biomarkers expression [ Time Frame: 6 months ] [ Designated as safety issue: No ]To perform immunohistochemistry for IGF-1R, pAKT ,mTOR, p-S6K, p-S6, p-4E-BP1, and pTEN expression in all pre-treatment tissue specimens of thymoma and thymic carcinoma and correlate with response and survival (PFS and OS).
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||January 2017|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Everolimus will be orally administered at the dosage of 10 mg once daily. Each cycle will be considered as 21 days of treatment. Tumor assessment will be done every two cycles.Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.
Other Name: Afinitor
Please refer to this study by its ClinicalTrials.gov identifier: NCT02049047
|Istituto Clinico Humanitas|
|Rozzano, MI, Italy, 20089|
|Principal Investigator:||Armando Santoro, MD||Istituto Clinico Humanitas|