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0S-12-1-A Randomized, Double-Blind, Multicenter, Phase III Study of Everolimus (RAD001) plus Best Supportive Care versus Placebo plus Best Supportive Care in the Treatment of Patients with Advanced NET of GI or Lung Origin - RADIANT-4

Description

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 advanced nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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 are allowed into the study. Pretreated patients must 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

  • 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 locoregional therapy within the last 6 months
  • 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 have 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 may apply.

Sites

  • California

    • USC/Kenneth Norris Comprehensive Cancer Center USC/Norris, Los Angeles, California, 90033
    • Cedars Sinai Medical Center SC, Los Angeles, California, 90048
    • Scripps Clinic Regulatory, La Jolla, California, 92121
  • Oregon

    • Oregon Health & Science University OH&SU, Portland, Oregon, 97239
  • Colorado

    • University of Colorado SC, Aurora, Colorado, 80045
  • Texas

    • Texas Oncology TX Oncology Baylor, Dallas, Texas, 75251
    • Texas Oncology Texas Oncology - Amarillo, Dallas, Texas, 75251
    • Texas Oncology, P.A. TX Onc Baylor, Dallas, Texas, 75251
    • Texas Oncology, P.A. Texas Oncology - Amarillo, Dallas, Texas, 75251
  • Illinois

    • University of Chicago Medical Center UC SC, Chicago, Illinois, 60546
  • Tennessee

    • Vanderbilt University Medical Center Vanderbilt Med Ctr, Nashville, Tennessee, 37232
  • Indiana

    • Indiana University Health Goshen Center for Cancer IU Health - SC, Indianapolis, Indiana, 46202
  • Italy

    • Novartis Investigative Site, Napoli, 80132
    • Novartis Investigative Site, Napoli, 80131
  • Czech Republic

    • Novartis Investigative Site, Brno, 65653
  • FI

    • Novartis Investigative Site, Firenze, FI, 50134
  • Germany

    • Novartis Investigative Site, Magdeburg, 39120
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