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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00363051
Registration number
NCT00363051
Ethics application status
Date submitted
2/08/2006
Date registered
15/08/2006
Date last updated
10/05/2013
Titles & IDs
Public title
Safety/Efficacy of Everolimus in Adults With Advanced Pancreatic Neuroendocrine Cancer Not Responsive to Chemotherapy
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Scientific 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
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Secondary ID [1]
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CRAD001C2239
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Islet Cell Carcinoma
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Neuroendocrine Carcinoma
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Neuroendocrine Tumor
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Pancreatic Neoplasms
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
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Kidney
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Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Pancreatic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Everolimus 10 mg
Treatment: Drugs - Octreotide Depot
Experimental: 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.
Treatment: Drugs: 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.
Treatment: Drugs: Octreotide Depot
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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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.
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Timepoint [1]
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from date of randomization/start of treatment until first documented response confirmed 4 weeks later( at least 3 months)
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Secondary outcome [1]
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Duration of Overall Response (Stratum 1) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
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Assessment method [1]
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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
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Timepoint [1]
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from date of first documented confirmed response to time to progression, at least 3 months
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Secondary outcome [2]
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Duration of Overall Response (Stratum 2) Based on Response Evaluation Criteria in Solid Tumors (RECIST)- Central Radiology Review
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Assessment method [2]
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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
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Timepoint [2]
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from date of first documented confirmed response to time to progression, at least 3 months
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Secondary outcome [3]
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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)
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Assessment method [3]
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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.
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Timepoint [3]
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from date of randomization/start of treatment until first documented response confirmed 4 weeks later (at least 3 months)
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Secondary outcome [4]
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Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs)[Stratum 1]
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Assessment method [4]
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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.
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Timepoint [4]
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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
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Secondary outcome [5]
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Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs) [Stratum 2]
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Assessment method [5]
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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.
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Timepoint [5]
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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
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Secondary outcome [6]
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Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 1)
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Assessment method [6]
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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.
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Timepoint [6]
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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
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Secondary outcome [7]
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Time to Progression Free Survival (PFS) Per Central Radiology Review (Stratum 2)
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Assessment method [7]
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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.
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Timepoint [7]
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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
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Secondary outcome [8]
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Time to Overall Survival (OS)(Stratum 1)
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Assessment method [8]
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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.
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Timepoint [8]
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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
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Secondary outcome [9]
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Time to Overall Survival (OS) (Stratum 2)
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Assessment method [9]
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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.
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Timepoint [9]
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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
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Secondary outcome [10]
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Everolimus Trough Level Determination by Pharmacokinetics Parameter in Both Strata (Stratum 1 and 2)
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Assessment method [10]
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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.
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Timepoint [10]
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Cycle 1 Day 15
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Secondary outcome [11]
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Effect of Octreotide Depot on the Trough Concentrations of Everolimus
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Assessment method [11]
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The effect of Octreotide Depot on the trough concentrations of everolimus was assessed at Cycle 1 Day 15.
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Timepoint [11]
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Cycle 1 Day 1, Cycle 2 Day 1
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2012
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Sample size
Target
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Accrual to date
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Final
160
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Novartis Investigative Site - Heidelberg
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Novartis Investigative Site - Herston
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Recruitment hospital [3]
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Novartis Investigative Site - Kogarah
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Recruitment postcode(s) [1]
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- Heidelberg
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Recruitment postcode(s) [2]
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- Herston
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Recruitment postcode(s) [3]
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- Kogarah
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Florida
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Georgia
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Iowa
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Louisiana
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Ohio
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Belgium
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Leuven
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Canada
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Ontario
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France
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Billancourt
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France
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France
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France
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Reims
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France
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Toulouse
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France
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Villejuif Cedex
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Germany
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Berlin
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Heidelberg
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Germany
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Marburg
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Germany
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Ulm
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Italy
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Milano
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Italy
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Modena
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Italy
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Pisa
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Italy
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Rome
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Italy
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Torrette di Ancona
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Netherlands
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Gronigen
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Spain
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Barcelona
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Spain
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L'Hospitalet de Llobregat
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Spain
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Madrid
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Sweden
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00363051
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00363051
Download to PDF