This study is in progress, not accepting new patients

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

a study on NET of GI OriginNET of Lung OriginNeuroendocrine Tumor

Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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 advanced nonfunctional neuroendocrine tumor of gastrointestinal or lung origin.

Official Title

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

Keywords

Advanced NET of GI OriginAdvanced NET of Lung OriginNeuroendocrine TumorsNeuroendocrine tumorNETprogressiveadvancedgastrointestinalGI or lung originnonfunctionaleverolimusSirolimusEverolimus + BSC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join 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 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.

Locations

  • University of California San Diego - Moores Cancer Center Regulatory
    La JollaCalifornia92093-0658United States
  • Scripps Clinic Regulatory
    La JollaCalifornia92121United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01524783
Phase
Phase 3
Study Type
Interventional
Last Updated