Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
NCT ID: NCT00363051
Last Updated: 2013-05-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2006-06-30
2012-04-30
Brief Summary
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Detailed Description
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Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day.
Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Everolimus 10 mg
Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day.
Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy.
Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Everolimus 10 mg
Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
Octreotide Depot
Interventions
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Everolimus 10 mg
Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced.
Octreotide Depot
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed low-grade or intermediate-grade neuroendocrine carcinoma
* Objective disease progression by Response Evaluation Criteria in Solid tumors (RECIST) criteria while receiving cytotoxic chemotherapy or at any time after receiving an adequate course of cytotoxic chemotherapy (i.e., at least 3 consecutive cycles or months of treatment with the same cytotoxic drug or regimen)
* Presence of at least one measurable disease using RECIST criteria at screening (computer tomography \[CT\] or Magnetic resonance imaging \[MRI\])
* Adequate bone marrow, liver and kidney function
* WHO Performance Status 0-2.
* Receiving treatment (at least 3 consecutive months) with Octreotide Depot.
* In addition to documentation of progressive disease on or after chemotherapy, patients in stratum 2 must have documented objective progression of disease while receiving Octreotide Depot.
Exclusion Criteria
* Patients with poorly differentiated neuroendocrine carcinoma
* Hepatic artery embolization within the last 6 months
* Prior therapy with everolimus or other rapamycins (sirolimus, temsirolimus)
* Other concurrent malignancy
* Other serious intercurrent infections or nonmalignant uncontrolled medical illnesses
Exclusion Criterion for Stratum 1 only:
• Received treatment with Octreotide Depot or any other long-acting somatostatin analogue in the 60 days prior to enrollment or any short-acting somatostatin analogue in the two weeks prior to enrollment.
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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The University of Alabama at Birmingham
Birmingham, Alabama, United States
USC Medical Center
Los Angeles, California, United States
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
University of Miami
Miami, Florida, United States
H. Lee Moffit Cancer Center & Research Institute
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
LSUHC Multispecialty Clinic
New Orleans, Louisiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Lynn Ratner, M.D.
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Arthur G. James Cancer Hospital/Ohio State University
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
M. D Anderson Cancer Center
Houston, Texas, United States
Scott & White Memorial Hospital
Temple, Texas, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Novartis Investigative Site
Buenos Aires, , Argentina
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Santa Fe, , Argentina
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Heidelberg, , Australia
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Herston, , Australia
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Kogarah, , Australia
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Leuven, , Belgium
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Billancourt, , France
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Clichy, , France
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Lyon, , France
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Reims, , France
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Toulouse, , France
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Villejuif, , France
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Berlin, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Frankfurt, , Germany
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Heidelberg, , Germany
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Marburg, , Germany
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Ulm, , Germany
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Milan, , Italy
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Modena, , Italy
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Pisa, , Italy
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Rome, , Italy
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Torrette Di Ancona, , Italy
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Gronigen, , Netherlands
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Barcelona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Madrid, , Spain
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Uppsala, , Sweden
Countries
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Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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CRAD001C2239
Identifier Type: -
Identifier Source: org_study_id
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