PHASE II STUDY OF EVEROLIMUS IN PATIENTS WITH THYMOMA AND THYMIC CARCINOMA PREVIOUSLY TREATED WITH CHEMOTHERAPY - ND

Phase 1

• Conditions: Chemotherapy pre-treated thymoma and thymic carcinoma patients who have had at least one prior platinum-containing chemotherapy regimen; MedDRA version: 9.1Level: LLTClassification code 10056296

• Registration Number: EUCTR2010-019683-37-IT
• Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-08
• Study Completion: 2019-05-05
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1.Signed and dated IRB/IEC-approved Informed Consent
2.Histological diagnosis of invasive recurrent or metastatic thymoma or thymic carcinoma confirmed by pathologist.
3.Patients must have had 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.
4.Patients must have 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.
5.Patients must have recovered from toxicity related to prior therapy to at least to grade 1 (defined by CTCAE 3.0).
6.Patients must not have had 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.
7.Age ? 18 years.
8.Life expectancy ? 3 months.
9.Performance status (ECOG) ? 2.
10.Negative pregnancy test (if female in reproductive years)
11.Patients must have adequate organ and marrow function (as defined below). Patients must have returned to baseline or grade 1 from any acute toxicity related to prior therapy:
12.Leukocytes ?3,000/mm
13.Absolute neutrophil count ?1,500/mm
14.Hemoglobin ? 9 g/dL
15.Platelets ?100,000/mm
16.Total bilirubin ? 1.5 x institutional upper limit of normal (ULN)
17.AST(SGOT)/ALT(SGPT) ? 3 x institutional ULN (5x if LFT elevations due to liver metastases)
18.Creatinine 1?.5 xinstitutional ULN
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 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.
2.Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
3.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
4.Pregnant or breast feeding women
5.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
6.Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceeding treatment start.
7.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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ?To evaluate the activity of Everolimus in patients with advanced or recurrent thymoma or thymic carcinoma by the determination of disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD).;Secondary Objective: ? To further characterize the efficacy of Everolimus in thymoma and thymic carcinoma patients by the determination of progression free survival (PFS), duration of response, and overall survival (OS).<br>? To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging.<br>? To evaluate the predictive role of the expression of several biomarkers by immunoistochemistry on tumor samples.<br>? to evaluate the safety profile of Everolimus in thymoma and thymic carcinoma patients;Primary end point(s): disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD)