Neoplasms

All Conditions

Rare Diseases

Neuroendocrine Tumors

Carcinoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neuroendocrine Tumor

Neuroepithelioma

Hypoglycemic Agents

All Drugs and Chemicals

Antineoplastic Agents

Metformin

Lanreotide

Dose and Treatment Regimen:

LANREOTIDE ATG 120 mg/28 days (equivalent to 1 cycle), deep subcutaneous injection (SC) in combination with METFORMIN 2550 mg daily (maximum dose), oral administration (OS).

Metformin starting dose 850 mg/day to be increased up to 1700 mg/day at day 14, 2550 mg/day at day 28, (maximum dose), if well tolerated.

Lanreotide and Metformin

Sara Pusceddu, MD

This is a Pilot, One-arm, Open-label, Prospective Study to evaluate Safety of Lanreotide 120 mg ATG in combination with Metformin in patients with advanced progressive GI or lung carcinoids.

The patient population will include patients with a histologically documented diagnosis of Well differentiated NET, G1-G2 according to the last WHO Classification criteria for GI and lung NET carcinoids.

This study is strategically positioned in the medical treatment safety and efficacy context, that is Lanreotide can be safely and effectively used in combination with other agents, like Metformin.

Aim of this study is to verify the safety of a concomitant administration of Lanreotide 120 mg ATG with Metformin in advanced, progressing gastro-intestinal or lung carcinoids patients, by accurately monitor patients from a tolerability point of view during all study long.

The MetNET-2 Trial

Safety of Lanreotide 120 mg ATG in Combination With Metformin in Patients With Progressive Advanced Well-differentiated Gastro-intestinal (GI) or Lung Carcinoids: A Pilot, One-arm, Open-label, Prospective Study: the MetNET-2 Trial

This is a pilot study. This endpoints should be considered an exploratory evaluation

Answers will be based on a 5 point Likert scale (1=completely satisfied, 2= rather satisfied, 3= unchanged, 4= rather dissatisfied, 5= completely dissatisfied).

Biochemical progression will be evaluated testing Chromogranin A, NSE, 5-HIAA (only if functioning tumours) at each 4th month

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Pasireotide

Hormones

Hormone Antagonists

Pasireotide LAR

Novartis Pharmaceuticals

This study designed to determine the Maximum Tolerated Dose (MTD) for patients with advanced Neuroendocrine Tumors (NETs) and to characterize the safety, tolerability, Pharmacokinetics and preliminary efficacy of pasireotide LAR administered i.m. once every 28 days.

Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)

A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs)

Frequency of dose-limiting toxicities (DLTs) at each dose level associated with q28 days administration of pasireotide LAR during the first 2 treatment cycles.

Incidence of adverse drug events, overall and by severity and incidence of serious adverse events and laboratory abnormalities. Also, changes in laboratory assessments, electrocardiograms, Holter monitor, imaging for gallstones, and assessment of physical examinations such as vital signs

Changes from baseline values in IGF-1, chromogranin A and neuron-specific enolase

Disease control rate (CR+PR+SD as assessed by RECIST 1.0). Also measure progression free survival (PFS).

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Pancreatic Neuroendocrine Tumor

Temozolomide

Lenograstim

Mitogens

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

Part 1: dose-escalation phase to determine MTD of TAS-102 in combination with Temozolomide (TMZ). Treatment cycles are 28 days, with TAS-102 administered orally twice daily days 1-5 and 8-12, and TMZ administered orally days 8-12. No treatment medications administered days 13-28 of each cycle. Growth factor support is required during Part 1 and should be dosed per institutional standards.

Part 2: expansion phase to evaluate preliminary efficacy of MTD. Subjects treated with the recommended phase 2 drug doses determined in part 1. Treatment will continue for up to 13 cycles (approx. 12 months). Growth factor support is allowed during Part 2 and should be dosed per institutional standards.

TAS-102

Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.

Filgrastim

Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.

Pegfilgrastim

Nataliya Uboha, MD

The goal of this study is to establish maximum tolerated doses/recommended phase 2 dose (RP2D) of temozolomide (TMZ) and TAS-102 when these agents are used in combination and to evaluate the safety profile of this drug combination.

The study is a two part phase 1B clinical trial consisting of three study periods: a screening period of 14 days or less, a treatment period, and a safety follow-up period 30 days after treatment discontinuation.

Part 1 is a dose finding phase with the objective to assess the safety and tolerability of the proposed drug combination and to identify the maximum tolerated dose (MTD) and a recommended phase 2 dose.

Part 2 is an open-label expansion study, which will enroll patients with metastatic pNETs who have not been previously treated with chemotherapy. Part 2 will obtain further safety data of the proposed drug combination.

Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs

Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic Neuroendocrine Tumors

Investigate the safety and determine the MTD of TAS-102 administered in combination with TMZ in patients with advanced NETs. Treatments will continue to disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST).

Response rate defined as the percentage of subjects with a confirmed complete response (CR) or partial response (PR), assessed as per RECIST criteria. Assessments performed using RECIST criteria.

Defined as the time from the start of treatment to the date of first documented progression or any cause of death during the study, assessed according to RECIST. Analyzed using the Kaplan-Meier method.

Defined as the time from the start of treatment to the date of expiration. Analyzed using the Kaplan-Meier method.

Defined as the percentage of patients who achieved complete response, partial response, and stable disease by investigator assessment as per RECIST.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

A major biochemical response will be defined as normalization or \>50% reduction in levels of Chromogranin A. Chromogranin A is elevated in up to 60% of functioning and nonfunctioning pancreatic endocrine tumors.

Taiho Pharmaceutical Co., Ltd.

University of Wisconsin, Madison

Symptoms and General Pathology

Frailty

Metronomic Temozolomide in unfit patients with advanced neuroendocrine neoplasms (NENs) Dosage and schedule: 60 mg/die continuosly

Metronomic temozolomide 60 mg/die continuously

Temozolomide capsule

Francesca Spada, MD, PhD

Darina Tamayo

Darina Tamayo, PharmSc.

Cristina Mazzon, Ph.D.

Manila Rubino, MD

Nicola Fazio, MD, PhD

Study design and rationale: Neuroendocrine neoplasms (NENs ) represent a heterogeneous group of malignancies, which differ in terms of behavio r and prognosis. Most of t hem are advanced at diagnosis t herefore systemic treatment is proposed. While over the last years many advanced have been made especially in terms of molecular targeted therapies (MTA) like everolimus and sunitinib, chemotherapy i n NENs still represents a controversial question. Temozolomide has been reported to be active alone or in combination with other drugs in neuroendocrine neoplasms (NENs) from different origin. So far there is not universal agreement on the right setting an d way of administration of this therapy. Objective: This is a multicentric phase II prospective interventional study to evaluate the clinical features of patients, who are judged unfit for systemic treatments, consecutively treated with a metronomic Temozolomide chemotherapy schedule in Italian centers with expertise in NEN and to explore also the methylation status of O6-methylguanine-DNA-methyltransferase (MGMT) and the polymorphism of thymidylate synthase (TS) by pyrosequencing in those patients of which tissues were available. This study will allow a better understanding of the role of metronomic temozolomide chemotherapy in NENs patients and help clinicians in answering some of the outstanding questions on their management. Method: Prospective analysis of clinical data of patients unfit for chemotherapy consecutively treated with metronomic temozolomide regimen in Italian centers with expertise in clinical and research NEN activity, for one year from the start of the accrual. Planning of study: Data from NENs patients of any age treated at these centers will be retrieved by searching the hospital information system and analysed. Eligible study population: Patients with histological diagnosis of low grade advanced NEN treated unfit for systemic treatments, for one year from the start of the accrual. Endpoints and evaluation parameters:

Description of efficacy and toxicity of Temozolomide regimen in patients with advanced NENs with different primary sites unfit for systemic treatment and explored the pote ntial correlation with clinical/biological factors.

Study design and trial duration This is an italian multicenter phase II trial of metronomic temozolomide in unfit patients with advanced NENs. The accrual will last 1-year and the follow up 2-year for a global 3-year period.

Objectives Primary endpoint Progression free survival (PFS).

Secondary endpoint Overall response rate (ORR) Duration of response (DOR) Overall survival (OS) Safety Quality of life (QoL)

Exploratory endpoint To evaluate O6 methylguanine DNA methyltransferase (MGMT) status in tumor tissue to validate the methods of MGMT determining and correlation with clinical outcomes

Overview on the study design Prospective analyses of consecutively NEN patients treated at Istituto Europeo di Oncologia IRCCS and participant centers between the end of 2021 and 2024 will be conducted. All patients who potentially benefit by these therapies will be proposed to participate to the study. The patient notes will then be assessed for eligibility as defined in the next section.

Treatment drug and schedule The regimen consists of oral temozolomide 60 mg once daily fasting continuously (28-day cycles)

Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study

An Italian Multicenter Phase II Trial of Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study

O6 methylguanine DNA methyltransferase (MGMT) status will be evaluate in tumor tissue to validate the methods of MGMT determining and correlation with clinical outcomes

PFS will be defined as the time from starting treatment to documented disease progression or death from any cause. For patients without documented progression or death at the time of analysis, PFS will be censored at the last actual visit date of tumor evaluation.

ORR will be defined as the percentage of patients with complete responses (CR) or partial responses (PR). Patients for whom overall best response is not CR or PR, as well as patients without any post baseline tumor assessment, will be considered non responders.

DOR will be defined as the time from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e.

patients with a CR or PR. DOR for patients who have not progressed or died at the time of analysis will be censored at the date of their last tumor assessment.

Overall survival (OS). OS will be defined as the time from starting treatment to death from any cause. Patients alive at the date of data cut off for analysis will be censored at the last date known to be alive.

Incidence of adverse events (AEs), with severity determined through use of the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0); change from baseline in targeted vital signs and physical findings ; change from baseline in targeted clinical laboratory test results

Mean changes from baseline score in patient function (physical, role, social, emotional, cognitive) and disease/treatment related symptoms by cycle, as assessed by a ll function scales and symptom items/scales of the EORTC QLQ C30, EORTC GI NET 2 and G8 test for frail elderly patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The MetNET-2 Trial	NCT02823691	Neuroendocrine ...	Lanreotide and ...	18 Years -	Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Dose Escalation Study of Pasireotide (SOM230) in Patients With Advanced Neuroendocrine Tumors (NETs)	NCT01364415	Neuroendocrine ...	Pasireotide LAR	18 Years -	Novartis
Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs	NCT02943733	Neuroendocrine ... Neoplasms Cancer Tumors	TAS-102 Temozolomide Filgrastim Pegfilgrastim	18 Years -	University of Wisconsin, Madison
Metronomic Temozolomide in Unfit NENs Patients Metronomic Temozolomide in Unfit Patients With Advanced Neuroendocrine Neoplasms (NENs): MeTe Study	NCT05554003	Neuroendocrine ... Frailty Chemotherapy Ef...	Temozolomide ca...	18 Years -	European Institute of Oncology
Safety of TAS-102 in Combination With Temozolomide for Metastatic Pancreatic NETs	NCT02943733	Neuroendocrine ... Neoplasms Cancer Tumors	TAS-102 Temozolomide Filgrastim Pegfilgrastim	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for nets

Every month we try and update this database with for nets cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for nets

Every month we try and update this database with for nets cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for nets cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.