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

NCT06472388 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 67420523.4.1001.5432
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Progression free survival rate at 12 months

  Proportion of patients without radiological progression or death at 12 months from first day of everolimus

  12 months

Secondary Outcomes (2)

• progression free survival

  12 months

• time to treatment failure

  12 months

Study Arms (2)

Everolimus 5

EXPERIMENTAL

oral everolimus 5 mg/daily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.

Drug: Everolimus 5 MG

Everolimus 10

ACTIVE COMPARATOR

oral everolimus 10 mg/daily continuously until progression or intolerance or consent withdrawal. dose reduction for toxicity is allowed.

Drug: Everolimus 5 MG

Interventions

Everolimus 5 MG DRUG

oral everolimus 5 mg/daily

Everolimus 10; Everolimus 5

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of well-differentiated Grade 1/Grade 2 NET from gastrointestinal, pancreatic, pulmonary or unknown primary sites.
• Metastatic or locally advanced and unresectable disease, measurable by images
• Disease progression by RECIST 1.1 in the last 6 months assessed by local investigators
• At least one previous line of systemic treatment (suspended for more than 3 weeks).
• Eastern Cooperative Oncology Group (ECOG) 0-2 o Good organ function:
• Hemoglobin \> 8 g/dL
• Neutrophils ≥ 1,500/mm³
• Platelets \> 90,000/mm³
• Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN \[upper limit of normal\] or ≤ 5 x ULN for patients with liver metastases
• Bilirubin ≤ 1.5 x ULN, creatinine \< 1.5 mg/dL

You may not qualify if:

• Aggressive disease requiring cytotoxic therapy
• Severe/uncontrolled comorbid conditions that deem participant unfit for everolimus therapy, as per investigators' judgement.
• MiNEN

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (2)

AC Camargo Cancer Center

São Paulo, São Paulo, 01509010, Brazil

RECRUITING

AC Camargo Cancer Center

São Paulo, 01509010, Brazil

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Disease Progression; Adenoma, Islet Cell; Carcinoid Tumor

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenoma; Neoplasms, Glandular and Epithelial; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Central Study Contacts

Rachel P Riechelmann, MD

CONTACT

+55112189500; rachel.riechelmann@accamargo.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: June 25, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)