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

NCT01524783 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2021-08-05

Study results available
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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.

Conditions

Interventions

DRUG

Everolimus

Participants were treated with everolimus 10 mg (two 5 mg tablets) once daily orally taken

DRUG

Placebo

Participants were treated with two tablets of matching placebo once daily orally taken.

OTHER

Best suportive care (BSC)

Best supportive care includes all care provided to participants deemed necessary by the treating physician, such as but not restricted to anti-diarrheals and analgesics. The optimal care of the patient is based on the treating physician's best medical judgment.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-30
Primary Completion
2014-11-28
Completion
2020-08-07
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • China
  • Colombia
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Lebanon
  • Netherlands
  • Poland
  • Russia
  • Saudi Arabia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01524783 on ClinicalTrials.gov