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Everolimus 5 mg vs 10 mg/Daily for Patients With Neuroendocrine Tumors

NCT06472388 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-25

No results posted yet for this study

Summary

Everolimus is approved in many countries to treat patients with advanced/metastatic well-differentiated neuroendocrine tumors (NET), providing median progression-free survival times of approximately 12 months across different types of NET. However, it is can cause severe adverse effects. Phase I trial demonstrated that a dose of 5mg/day/week was sufficient to inhibit cell proliferation by blocking the mTOR pathway.

This is a randomized, open-label, phase II near-equivalence clinical trial of oral everolimus 5 mg vs 10 mg oral/daily and continuously in patients with Grade 1 or Grade 2 metastatic NET, with tumor progression or intolerance to at least one line of treatment and with radiological disease progression within 6 months.

Conditions

  • Neuroendocrine Tumors
  • Progression
  • Neuroendocrine Tumor Grade 1
  • Neuroendocrine Tumor Grade 2
  • Neuroendocrine Tumor of Pancreas
  • Neuroendocrine Tumor of the Lung
  • Neuroendocrine Tumor Carcinoid

Interventions

DRUG

Everolimus 5 MG

oral everolimus 5 mg/daily

Sponsors & Collaborators

  • AC Camargo Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-24
Primary Completion
2026-05-20
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

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 NCT06472388 on ClinicalTrials.gov