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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02049047
Other study ID # ONC-2010-001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2011
Est. completion date January 2019

Study information

Verified date September 2022
Source Istituto Clinico Humanitas
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date January 2019
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histological diagnosis of invasive recurrent or metastatic thymoma or thymic carcinoma confirmed by pathologist. - At least one prior platinum-containing chemotherapy regimen. There is no limit to the number of prior chemotherapy regimens received. Progressive disease should have been documented before entry into the study. - Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan. - Patients must have recovered from toxicity related to prior therapy to at least to grade 1 (defined by CTCAE 3.0). - No major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study. - Life expectancy of at least 3 months. - Performance status (ECOG)<=2 - Negative pregnancy test (if female in reproductive years) - Adequate organ and marrow function (as defined below) - Leukocytes >=3,000/mm, Absolute neutrophil count >=1,500/mm, Hemoglobin>= 9 g/dL, Platelets>= 100,000/mm, Total bilirubin >= 1.5 x institutional upper limit of normal (ULN), AST(SGOT)/ALT(SGPT)>= 3 x institutional ULN (5x if LFT elevations due to liver metastases, )Creatinine <= 1.5 x institutional ULN Exclusion Criteria: - Patients with symptomatic brain metastases. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator. - Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment - Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy - Pregnant or breast feeding women - Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri - Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceding treatment start. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.

Study Design


Intervention

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.

Locations

Country Name City State
Italy Istituto Clinico Humanitas Rozzano MI

Sponsors (1)

Lead Sponsor Collaborator
Armando Santoro, MD

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary disease control rate disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD), of Everolimus monotherapy 6 months
Secondary 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. 6 months
Secondary 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 6 months
Secondary 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. 6 months
Secondary FDG-PET imaging relations To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging. 6 weeks
Secondary safety profile Overall safety profile, evaluated on the basis of laboratory and clinical safety parameters 6 months
Secondary 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). 6 months
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