A Phase 2 interventional study of Everolimus in Thymoma and Thymic Carcinoma, sponsored by Armando Santoro, MD. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by Armando Santoro, MD · Phase 2, Interventional, and Treatment
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. 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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 41 is close to the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Armando Santoro, MD is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
oral everolimus
Drug: Everolimus
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.
Also known as: Afinitor
disease control rate
disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD), of Everolimus monotherapy
Time frame: 6 months
PFS
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.
Time frame: 6 months
Duration of Response
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
Time frame: 6 months
OS
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.
Time frame: 6 months
FDG-PET imaging relations
To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging.
Time frame: 6 weeks
safety profile
Overall safety profile, evaluated on the basis of laboratory and clinical safety parameters
Time frame: 6 months
biomarkers expression
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).
Time frame: 6 months
Plan to share: No — not planned
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Armando Santoro, MD