Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02687958
Eligibility Criteria:
Inclusion Criteria:
* Histological / cytological diagnosis of GEP Neuroendocrine Carcinoma (NEC) with Ki67\< 55% (WHO 2010)
* Histological/cytological diagnosis of large-cells neuroendocrine carcinoma of the lung with Ki67 \<55%;
* Stable disease, partial response or complete response (Recist 1.1) after 6 cycles of first line chemotherapy with Cisplatin plus Etoposide or alternative first line chemotherapy according with local practice
* non functional NEC
* locally advanced inoperable or metastatic disease
* measurable or evaluable disease according to RECIST criteria (version 1.1)
* Age\> 18;
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
* Adequate bone marrow function (Hb\> 9.0 g / dL, absolute neutrophil count\> 1.5 x 109 / L, platelets\> 100 x 109 / L), renal function (serum creatinine \<2 mg / dL x upper limit of normal (ULN) or creatinine clearance, Cockroft formula, ≥ 30 ml / min), hepatic function (serum bilirubin \<1.5 x ULN, serum transaminases \<2.5 x ULN in the absence of liver metastases or \<5x ULN in the presence of liver metastases);
* Negative pregnancy test or breastfeeding women during childbearing age;
* Written informed consent;
* Approval of the Ethics Committee that will be required.
Exclusion Criteria:
* clinically significant cardiovascular disorders in the 6 months prior to randomization (congestive heart failure, myocardial infarction, unstable angina, severe uncontrolled cardiac arrhythmia, arterial thrombosis, cerebrovascular accidents, pulmonary thromboembolism);
* Functional Neuroendocrine Carcinoma NEC
* Neuroendocrine carcinoma with ki 67 \> 55%
* ongoing uncontrolled infection;
* Concomitant intake of:
* Drugs incompatible with concomitant everolimus;
* Any other drug in clinical trials;
* History of other malignancy except carcinoma in situ of the cervix or basal / squamous cell carcinoma of the skin adequately treated;
* Presence of brain metastases;
* Any other serious or uncontrolled concurrent disease conditions that the safe administration of medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02687958
Study Brief:
Protocol Section:
NCT02687958