Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors
NCT ID: NCT00510068
Last Updated: 2015-07-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
410 participants
INTERVENTIONAL
2007-07-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Everolimus 10 mg/day
Participants received 10 mg per day of Everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
Everolimus
A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.
Placebo
Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
Everolimus Placebo
a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.
Interventions
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Everolimus
A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.
Everolimus Placebo
a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Measurable disease by radiologic assessment
3. Adequate blood work
4. Performance Status 0-2 : Ability to be out of bed most of the time
5. Adult male or female patients ≥ 18 years of age
6. Women of childbearing potential must have a negative serum pregnancy test
7. Written informed consent from patients must be obtained in accordance to local guidelines
Exclusion Criteria
2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting this trial
3. 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
4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus, temsirolimus, everolimus).
5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled medical conditions such as:
6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
7. Patients with a known history of HIV seropositivity
8. No other prior or concurrent cancer at the time enrolling to this trial
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2)
Mobile, Alabama, United States
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
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Brussels, , Belgium
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Leuven, , Belgium
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Fortaleza, Ceará, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Strasbourg, France, France
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Besançon, , France
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Clichy, , France
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Dijon, , France
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Lille, , France
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Lyon, , France
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Marseille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Reims, , France
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Toulouse, , France
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Villejuif, , France
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Mainz, Germany, Germany
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Bad Berka, , Germany
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Berlin, , Germany
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Marburg, , Germany
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München, , Germany
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Athens, GR, Greece
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Athens, , Greece
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Bologna, BO, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Modena, MO, Italy
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Pisa, PI, Italy
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Kashiwa, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Chuo-ku, Tokyo, Japan
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Groningen, , Netherlands
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Martin, Slovak Republic, Slovakia
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Barcelona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Uppsala, , Sweden
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Zurich, Switzerland, Switzerland
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Taipei, Taiwan, Taiwan
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Taipei, Taiwan, ROC, Taiwan
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Kaohsiung City, , Taiwan
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Lin-Ko, , Taiwan
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Bangkok, , Thailand
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Songkhla, , Thailand
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Withington, Greater Manchester, United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
Countries
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References
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Chan DL, Yao JC, Carnaghi C, Buzzoni R, Herbst F, Ridolfi A, Strosberg J, Kulke MH, Pavel M, Singh S. Markers of Systemic Inflammation in Neuroendocrine Tumors: A Pooled Analysis of the RADIANT-3 and RADIANT-4 Studies. Pancreas. 2021 Feb 1;50(2):130-137. doi: 10.1097/MPA.0000000000001745.
Yao JC, Voi M, Lincy J, Pavel M. Reply to V. Amoroso et al. J Clin Oncol. 2017 May 1;35(13):1488-1489. doi: 10.1200/JCO.2017.71.3875. Epub 2017 Jan 23. No abstract available.
Yao JC, Pavel M, Lombard-Bohas C, Van Cutsem E, Voi M, Brandt U, He W, Chen D, Capdevila J, de Vries EGE, Tomassetti P, Hobday T, Pommier R, Oberg K. Everolimus for the Treatment of Advanced Pancreatic Neuroendocrine Tumors: Overall Survival and Circulating Biomarkers From the Randomized, Phase III RADIANT-3 Study. J Clin Oncol. 2016 Nov 10;34(32):3906-3913. doi: 10.1200/JCO.2016.68.0702. Epub 2016 Sep 30.
Lombard-Bohas C, Yao JC, Hobday T, Van Cutsem E, Wolin EM, Panneerselvam A, Stergiopoulos S, Shah MH, Capdevila J, Pommier R. Impact of prior chemotherapy use on the efficacy of everolimus in patients with advanced pancreatic neuroendocrine tumors: a subgroup analysis of the phase III RADIANT-3 trial. Pancreas. 2015 Mar;44(2):181-9. doi: 10.1097/MPA.0000000000000262.
Yao JC, Shah MH, Ito T, Bohas CL, Wolin EM, Van Cutsem E, Hobday TJ, Okusaka T, Capdevila J, de Vries EG, Tomassetti P, Pavel ME, Hoosen S, Haas T, Lincy J, Lebwohl D, Oberg K; RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011 Feb 10;364(6):514-23. doi: 10.1056/NEJMoa1009290.
Other Identifiers
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2006-006819-75
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001C2324
Identifier Type: -
Identifier Source: org_study_id
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