Protocol
12-250
Full 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 - RADIANT-4
Purpose
Everolimus is a drug approved for treating neuroendocrine tumors that start in the pancreas (“pancreatic NETs”) after the cancer has progressed despite prior treatment. It works by inhibiting mTOR, a protein involved in cancer growth.
In this study, researchers want to evaluate the safety and effectiveness of everolimus in patients with advanced or inoperable neuroendocrine tumors that began in the lungs or digestive tract (with the exception of pancreatic NETs). Patients will be randomly assigned to receive everolimus or a placebo. All patients will also receive best supportive care.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have an advanced or inoperable neuroendocrine tumor that began in the lungs or digestive tract. Patients with pancreatic NETs may not participate in this study.
- Patients may have had no treatment, or may have experienced tumor progression despite no more than one prior regimen of chemotherapy.
- Patients may not have had prior mTOR therapy.
- Among patients who have had prior therapy, at least 4 weeks must have passed since completion of previous treatment and entry into the study (6 months for peptide radionuclide receptor therapy).
- This study is open to patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Diane Reidy-Lagunes at 646-888-4185.
Disease(s)
Lung Cancer
Upper Gastrointestinal
Upper Gastrointestinal: Neuroendocrine
Locations
Related Diseases
