Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
1 other identifier
interventional
160
11 countries
54
Brief Summary
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
Longer than P75 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 2, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2008
CompletedResults Posted
Study results publicly available
March 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 10, 2013
May 1, 2013
1.6 years
August 2, 2006
December 2, 2011
May 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
Objective response rate was defined by RECIST criteria: Partial response (PR) must have ≥ 30% decrease in the sum of longest diameter of all target lesions, from the baseline sum. Complete response (CR) must have disappearance of all target and non-target lesions. For CR or PR, tumor measurements must be confirmed by 2nd assessments within 4 weeks. Progression = 20% increase in the sum of longest diameter of all target lesions, from smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
Secondary Outcomes (11)
Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
from date of first documented confirmed response to time to progression, at least 3 months
Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
from date of first documented confirmed response to time to progression, at least 3 months
Objective Response Rate: Percentage of Participants With Best Over All Response of Complete Response or Partial Response by Central Radiology Review (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)
from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
on or after the day of the first intake of study treatment to starting no later than 28 days after study treatment discontinuation, at least every month
- +6 more secondary outcomes
Study Arms (1)
Everolimus 10 mg
EXPERIMENTALStratum 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Advanced (unresectable or metastatic) biopsy-proven pancreatic Neuroendocrine tumor (NET)
- 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.
You may not qualify if:
- Anticancer therapy within 3 weeks of enrollment.
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
The University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
USC Medical Center
Los Angeles, California, 90033, United States
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
Los Angeles, California, 90048, United States
UCLA Medical Center
Los Angeles, California, 90073, United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115, United States
University of Miami
Miami, Florida, 33136, United States
H. Lee Moffit Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
LSUHC Multispecialty Clinic
New Orleans, Louisiana, 70115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Lynn Ratner, M.D.
New York, New York, 10028, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Arthur G. James Cancer Hospital/Ohio State University
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239-3098, United States
M. D Anderson Cancer Center
Houston, Texas, 77030, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792, United States
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Santa Fe, Argentina
Novartis Investigative Site
Heidelberg, Australia
Novartis Investigative Site
Herston, Australia
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Kogarah, Australia
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Leuven, Belgium
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B34 2Y9, Canada
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London, Ontario, N6A 4L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Billancourt, 92100, France
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Clichy, 92118, France
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Lyon, 03, 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, 20141, Italy
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Modena, Italy
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Pisa, 56126, Italy
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Rome, 00189, Italy
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Torrette Di Ancona, 60020, Italy
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Gronigen, Netherlands
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Barcelona, 08035, Spain
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L'Hospitalet de Llobregat, Spain
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Madrid, 28040, Spain
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Uppsala, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Novartis Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2006
First Posted
August 15, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2008
Study Completion
April 1, 2012
Last Updated
May 10, 2013
Results First Posted
March 30, 2012
Record last verified: 2013-05