An Italian multicenter phase II trial of Metronomic Temozolomide in unfit patients with advanced neuroendocrine neoplasms (NENs): MeTe study - MeTe Study

ISTITUTO EUROPEO DI ONCOLOGIA0 个研究点目标入组 46 人开始时间: 2021年8月17日最近更新: 2021年12月13日

适应症

试验速览

暂无简介。

•Age > 18 years;
•Histologically proven diagnosis of low grade GEP-NENs (in accordance with WHO 2019 classification), bronchial carcinoids (in accordance with the Travis classification), low grade of unknown primary sites NENs;
•Advanced disease (unresectable locally advanced or metastatic);
•ECOG performance status 2 and/or moderate medullary impairment (Hb concentration <10-8 gr/dl; WBC <3000-2000/mm3; platelets <75000-50000/mm3; neutrophil count <1500- 1000/mm3); renal failure (eGFR o CrCl 30-59 ml/min – G2) and/or moderate liver failure (Child B 7-9) and/or severe comorbidities and/or > 3 prior systemic antitumor therapies (apart from SSA);
•Functioning/non functioning;
•Morphological progressive disease (CT scan or MRI);
•Clinical progression (as judged by the investigator).
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 26

•Patients pretreated with Temozolomide
•Are Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol
•Patients that did not sign written informed consent prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law
•Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.

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