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

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced NET of GI Origin, Advanced NET of Lung Origin, Neuroendocrine Tumors

In brief

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.

Key facts

Study ID

NCT01524783

Run by

Novartis Pharmaceuticals

People needed

302

Starts

2012-03-30

Expected to finish

2020-08-07

Last updated by the study team

2021-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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/exclusion criteria might apply.

Where it is running

• Scripps Clinic Regulatory — La Jolla, California, United States
• Cedars Sinai Medical Center SC — Los Angeles, California, United States
• University of Colorado Cancer Centre SC — Aurora, Colorado, United States
• H Lee Moffitt Cancer Center and Research Institute HLM — Tampa, Florida, United States
• University of Chicago UC SC — Chicago, Illinois, United States
• Goshen Center for Cancer Care IU Health SC — Indianapolis, Indiana, United States
• Dana Farber Cancer Institute SC — Boston, Massachusetts, United States
• Memorial Sloan Kettering MSkCC SC — New York, New York, United States
• Montefiore Medical Center MMC — The Bronx, New York, United States
• Oregon Health and Science University OH&SU — Portland, Oregon, United States
• Vanderbilt University Medical Center Vanderbilt Med Ctr — Nashville, Tennessee, United States
• Texas Oncology P A Texas Oncology Amarillo — Dallas, Texas, United States
• Texas Oncology P A TX Oncology Baylor — Dallas, Texas, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center UT MD Anderson Cancer Ctr — Houston, Texas, United States
• University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc — Madison, Wisconsin, United States
• Novartis Investigative Site — Innsbruck, Tyrol, Austria
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Edegem, Antwerpen, Belgium
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — Calgary, Alberta, Canada
• Novartis Investigative Site — Vancouver, British Columbia, Canada
• University of California San Diego - Moores Cancer Center Regulatory — La Jolla, California, United States

Full record on ClinicalTrials.gov

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