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

Sponsor
AC Camargo Cancer Center
Study ID
NCT06472388
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Everolimus 5 MG — DRUG
    oral everolimus 5 mg/daily

Study Details

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.

Key Dates

First listed
Jun 25, 2024
Start date
Apr 24, 2024
Status verified
Jun 2024
Primary completion
May 20, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Everolimus 5
    oral everolimus 5 mg/daily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.
  • Active Comparator: Everolimus 10
    oral everolimus 10 mg/daily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.

Primary Outcome Measure

Progression free survival rate at 12 months [ Time Frame: 12 months ]

Central Contacts

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