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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510898-24-00

Acronym

IEO 1411

Enrollment

Registered

2024-03-11

Start date

2022-01-14

Completion date

Unknown

Last updated

2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with well differentiated neuroendocrine neoplasia (NENs) not eligible for active antitumoral treatments due to their clinical conditions.

Brief summary

Progression free survival (PFS)

Detailed description

Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs, Duration of response, Overall survival (OS)., Safety, Quality of life (QoL), 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

Interventions

DRUGTEMOZOLOMIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival (PFS)	—

Secondary

Measure	Time frame
Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs, Duration of response, Overall survival (OS)., Safety, Quality of life (QoL), 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	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026