Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced Neuroendocrine Tumors of Pancreatic Origin

In brief

The purpose of this study was to evaluate progression free survival in those participants assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.

Key facts

Study ID

NCT00510068

Run by

Novartis Pharmaceuticals

People needed

410

Starts

2007-07-01

Expected to finish

2014-03-01

Last updated by the study team

2015-07-01

Who can join

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

You may qualify if…

• Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET
• Measurable disease by radiologic assessment
• Adequate blood work
• Performance Status 0-2 : Ability to be out of bed most of the time
• Adult male or female patients ≥ 18 years of age
• Women of childbearing potential must have a negative serum pregnancy test
• Written informed consent from patients must be obtained in accordance to local guidelines

You may not qualify if…

• Patients with severe kind of (poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small cell carcinoma) cancer are not eligible
• Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial
• Hepatic artery procedure called embolization within the last 6 months (1 month if there are other sites of measurable disease), or cryoablation/ radiofrequency ablation of hepatic metastasis within 2 months of enrollment
• Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus, temsirolimus, everolimus).
• Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled medical conditions such as:
• Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
• Patients with a known history of HIV seropositivity
• No other prior or concurrent cancer at the time enrolling to this trial
• Other protocol defined inclusion/ exclusion criteria applied

Where it is running

• Pacific Cancer Medical Center, Inc. — Anaheim, California, United States
• Cedars Sinai Medical Center SC-2 — Los Angeles, California, United States
• University of California at Los Angeles UCLA (3) — Los Angeles, California, United States
• University of California San Francisco Dept. of UCSF Comp. Cancer — San Francisco, California, United States
• Kaiser Permanente Northwest Franklin Medical Offices — Denver, Colorado, United States
• H. Lee Moffitt Cancer Center & Research Institute Malignant Hematology Clinic — Tampa, Florida, United States
• Indiana University Health Goshen Center for Cancer Dept. of Indiana Univ. Cancer — Indianapolis, Indiana, United States
• University of Iowa Medical Center Dept. of Iowa Medical Center — Iowa City, Iowa, United States
• University of Louisville / James Graham Brown Cancer Center SC — Louisville, Kentucky, United States
• LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Dept. of Neuroendocrine Clinic — New Orleans, Louisiana, United States
• Boston Medical Center BMC — Boston, Massachusetts, United States
• Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (4) — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Littleton Regional Hospital Dept. of Hematology/Oncology — Littleton, New Hampshire, United States
• Columbia University Medical Center- New York Presbyterian Dept. of Columbia Med. Center — New York, New York, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States
• Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept. of OHSU Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University Dept. of OHSU (3) — Portland, Oregon, United States
• St. Luke's Hospital and Health Network St. Luke's Cancer Network — Bethlehem, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center Hillman Cancer Center — Pittsburgh, Pennsylvania, United States
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
• University of Texas/MD Anderson Cancer Center Dept of MD Anderson CancerCent — Houston, Texas, United States
• Novartis Investigative Site — Brussels, Belgium
• University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2) — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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