Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

Study summary

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEverolimus and Placebo

Plus 1 other study approaches.

Who it may be forAdvanced NET of GI Origin · Advanced NET of Lung Origin

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 5, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?97 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: Everolimus; Drug: Placebo; Other: Best suportive care (BSC)

Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Supportive or behavioral care→

Study topics

Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Pathologically confirmed, well differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumor of GI or lung origin
No history of and no active symptoms related to carcinoid syndrome
In addition to treatment-naive patients, patients previously treated with SSA, Interferon (IFN), one prior line of chemotherapy, and/or PRRT were allowed into the study. Pretreated patients had to have progressed on or after the last treatment
Radiological documented disease progression within 6 months prior to randomization
Measurable disease
WHO performance status ≤1
Adequate bone marrow, liver and renal function

Reasons someone may not be able to joinExclusion criteria

Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, large cell neuroendocrine carcinoma and small cell carcinoma
Patients with pancreatic NET or NET of origins other than GI or Lung
Patients with history of or active symptoms of carcinoid syndrome (e.g. flushing, diarrhea)
Patients with more than one line of prior chemotherapy
Prior targeted therapy
Hepatic intra-arterial embolization within the last 6 months. Cryoablation or radiofrequency ablation of hepatic metastases within 2 months of randomization
Prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus)
Known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus)
Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral everolimus
Uncontrolled diabetes mellitus as defined by HbA1c \>8% despite adequate therapy
Patients who had any severe and/or uncontrolled medical conditions such as:
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia
active or uncontrolled severe infection
liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA)
Chronic treatment with corticosteroids or other immunosuppressive agents
Known history of HIV seropositivity
Pregnant or nursing (lactating) women Other protocol-defined inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of California San Diego - Moores Cancer Center RegulatoryLa Jolla, California
Scripps Clinic RegulatoryLa Jolla, California
Cedars Sinai Medical Center SCLos Angeles, California
University of Colorado Cancer Centre SCAurora, Colorado
H Lee Moffitt Cancer Center and Research Institute HLMTampa, Florida
University of Chicago UC SCChicago, Illinois
Goshen Center for Cancer Care IU Health SCIndianapolis, Indiana
Dana Farber Cancer Institute SCBoston, Massachusetts
Memorial Sloan Kettering MSkCC SCNew York, New York
Montefiore Medical Center MMCThe Bronx, New York
Oregon Health and Science University OH&SUPortland, Oregon
Vanderbilt University Medical Center Vanderbilt Med CtrNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2021. Always confirm current availability with the study team.

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