TEMOZOLOMIDE for Well-differentiated neuroendocrine neoplasm (NEN) | Gastroenteropancreatic neuroendocrine tumor (GEP-NEN) | Bronchial carcinoid

Inclusion criteria

• {"criterion_text":"- Age > 18 years\n- 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\n- Advanced disease (unresectable locally advanced or metastatic);\n- ECOG performance status 2 and/or moderate medullary impairment (at least one of the following criteria: 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)\n- Functioning/non functioning\n- Clinical and/or radiological progressive disease (CT scan or MRI);\n- Recovery from toxicities related to any prior treatments, adequate wash-out period from previous treatments\n- Ability to swallow pills\n- Fertile men should agree to use effective contraceptive methods up to 6 months after the last temozolomide intake and should be informed about the possible irreversible infertility related to temozolomide intake."}

Exclusion criteria

• {"criterion_text":"- 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;\n- 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\n- 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\n- Patients treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit\n- Hypersensitivity to the active substance or to any of the excipients, hypersensitivity to dacarbazine (DTIC), known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before study entry, pregnant or lactating females, patients on chronic treatment with valproic acid."}

Primary endpoints

• {"endpoint_text":"- Progression free survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs","definition_or_measurement_approach":"ORR defined as complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs"}
• {"endpoint_text":"- Duration of response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS).","definition_or_measurement_approach":""}
• {"endpoint_text":"- Safety","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life (QoL)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination","definition_or_measurement_approach":"Centralized evaluation of MGMT status in tumor tissue to correlate with clinical outcomes and to validate the MGMT determination method"}

Italy

Earliest CTIS Part Ii Submission Date

07-02-2024

Latest Decision Or Authorization Date

11-03-2024

Processing Time Days

33

Number Of Sites

10

Number Of Participants

46

Primary sponsor

Full Name

Istituto Europeo Di Oncologia S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"sponsorDuties code 8","organisation_type":"Pharmaceutical company"}