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Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

Primary Purpose

Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Everolimus 10 mg
Octreotide Depot
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Islet Cell Carcinoma focused on measuring Pancreatic, Tumor, Islet Cell, Carcinoma, Neuroendocrine, Endocrine, Atypical Carcinoid, RADIANT1, RADIANT-1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria for both strata: 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. Inclusion criteria for Stratum 2 only: Meet all inclusion criteria defined above for both strata. 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 for both strata: 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 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. Other protocol-defined inclusion/exclusion criteria applied.

Sites / Locations

  • The University of Alabama at Birmingham
  • USC Medical Center
  • Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
  • UCLA Medical Center
  • UCSF Comprehensive Cancer Center
  • University of Miami
  • H. Lee Moffit Cancer Center & Research Institute
  • Emory University Hospital
  • University of Iowa Hospitals and Clinics
  • LSUHC Multispecialty Clinic
  • Dana Farber Cancer Institute
  • Mayo Clinic
  • Dartmouth Hitchcock Medical Center
  • Lynn Ratner, M.D.
  • Duke University Medical Center
  • Arthur G. James Cancer Hospital/Ohio State University
  • Oregon Health and Science University
  • M. D Anderson Cancer Center
  • Scott & White Memorial Hospital
  • University of Wisconsin Hospital & Clinics
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Everolimus 10 mg

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR): Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR): Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
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)
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.
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals.
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals.
Time to Overall Survival (OS)(Stratum 1)
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.
Time to Overall Survival (OS) (Stratum 2)
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.
Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.
Effect of Octreotide Depot on the Trough Concentrations of Everolimus
The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.

Full Information

First Posted
August 2, 2006
Last Updated
May 6, 2013
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00363051
Brief Title
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
Official Title
An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Islet Cell Carcinoma, Neuroendocrine Carcinoma, Neuroendocrine Tumor, Pancreatic Neoplasms
Keywords
Pancreatic, Tumor, Islet Cell, Carcinoma, Neuroendocrine, Endocrine, Atypical Carcinoid, RADIANT1, RADIANT-1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus 10 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Everolimus 10 mg
Other Intervention Name(s)
RAD001
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Octreotide Depot
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
Secondary Outcome Measure Information:
Title
Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Description
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR): Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
Time Frame
from date of first documented confirmed response to time to progression, at least 3 months
Title
Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
Description
Duration of overall response applies only to patients whose best overall response was complete response (CR) or partial response (PR): Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression. Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions
Time Frame
from date of first documented confirmed response to time to progression, at least 3 months
Title
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)
Description
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.
Time Frame
from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
Title
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
Description
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame
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
Title
Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
Description
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
Time Frame
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
Title
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
Description
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals.
Time Frame
from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Title
Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
Description
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The Kaplan-Meier estimate of the PFS survival function was constructed. Median PFS was obtained and displayed along with 95% confidence intervals.
Time Frame
from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 September 2010
Title
Time to Overall Survival (OS)(Stratum 1)
Description
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.
Time Frame
from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Title
Time to Overall Survival (OS) (Stratum 2)
Description
Overall survival measures the time of survival , with any response or disease progression, until death. The OS is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival was censored at the date of last contact. In each treatment stratum, the Kaplan-Meier estimate of the overall survival function was constructed.
Time Frame
from randomisation to dates of disease progression, death from any cause, reported between day of first patient randomised, 26 June 2006, until cut-off date 13 April 2012
Title
Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
Description
For all patients in both strata, a blood sample for everolimus trough level determination will be collected immediately prior to the everolimus administration on Cycle 1 Day 15, Cycle 2 Day 1, and every month thereafter. A treatment cycle was defined as 28 days of consecutive daily treatment with everolimus and treatment continued until tumor progression. It is critical that patients not take their daily everolimus dose before the sample is drawn.
Time Frame
Cycle 1 Day 15
Title
Effect of Octreotide Depot on the Trough Concentrations of Everolimus
Description
The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.
Time Frame
Cycle 1 Day 1, Cycle 2 Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria for both strata: 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. Inclusion criteria for Stratum 2 only: Meet all inclusion criteria defined above for both strata. 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 for both strata: 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 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. Other protocol-defined inclusion/exclusion criteria applied.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars-Sinai Outpatient Cancer Center/Samuel Oschin Comprehensive Cancer Inst.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
H. Lee Moffit Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
LSUHC Multispecialty Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Lynn Ratner, M.D.
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Arthur G. James Cancer Hospital/Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
M. D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Scott & White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Novartis Investigative Site
City
Buenos Aires
Country
Argentina
Facility Name
Novartis Investigative Site
City
Santa Fe
Country
Argentina
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Australia
Facility Name
Novartis Investigative Site
City
Herston
Country
Australia
Facility Name
Novartis Investigative Site
City
Kogarah
Country
Australia
Facility Name
Novartis Investigative Site
City
Leuven
Country
Belgium
Facility Name
Novartis Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B34 2Y9
Country
Canada
Facility Name
Novartis Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Novartis Investigative Site
City
Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Novartis Investigative Site
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Novartis Investigative Site
City
Lyon Cedex
ZIP/Postal Code
03
Country
France
Facility Name
Novartis Investigative Site
City
Reims
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse
Country
France
Facility Name
Novartis Investigative Site
City
Villejuif Cedex
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
Country
Germany
Facility Name
Novartis Investigative Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Novartis Investigative Site
City
Modena
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Novartis Investigative Site
City
Rome
ZIP/Postal Code
00189
Country
Italy
Facility Name
Novartis Investigative Site
City
Torrette di Ancona
ZIP/Postal Code
60020
Country
Italy
Facility Name
Novartis Investigative Site
City
Gronigen
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
L'Hospitalet de Llobregat
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Novartis Investigative Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.novartisclinicaltrials.com/webapp/etrials/searchTrial.do?t=i&trialID=525&diseaseID=92
Description
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Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy

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