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Study of Everolimus as Maintenance Therapy for Metastatic NEC With Pulmonary or Gastroenteropancreatic Origin

NCT02687958 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-30

No results posted yet for this study

Summary

Cisplatin and Etoposide is the standard of care in NEC originating from the gastro-intestinal tract and lung, based on retrospective studies.

Nevertheless the prognosis of this group of patients is still poor with median survival of less than 20 months.

Everolimus is an mammilian target of rapamycin (mTOR) inhibitor that has been demonstrated to be active in patients with well and moderately differentiated primitive neuroectodermal tumor (pNET).

Recently, the Investigators demonstrated that the mammilian target of rapamycin (mTOR) pathway is overexpressed in NEC.

Based on the activity of Everolimus in the treatment of patients with well and moderately differentiated p-NET and on the evidence that even poorly differentiated forms express the pathway of m-TOR is conceivable that Everolimus could be active even in NEC.

Conditions

  • Neuroendocrine Carcinoma

Interventions

DRUG

Everolimus

Maintenance therapy

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Gruppo Oncologico Italiano di Ricerca Clinica

    lead OTHER

Principal Investigators

  • Francesco Di Costanzo, MD · AOU Careggi

  • Lorenzo Antonuzzo, MD · AOU Careggi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687958 on ClinicalTrials.gov