E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chemotherapy pre-treated thymoma and thymic carcinoma patients who have had at least one prior platinum-containing chemotherapy regimen |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10056296 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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). To correlate response to therapy with changes in FDG-PET imaging at baseline and first restaging. To evaluate the predictive role of the expression of several biomarkers by immunoistochemistry on tumor samples. to evaluate the safety profile of Everolimus in thymoma and thymic carcinoma patients |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
disease control rate (DCR), considered as complete response (CR) plus partial response (PR) plus stable disease (SD) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |