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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/NCT01525550
Registration number
NCT01525550
Ethics application status
Date submitted
13/01/2012
Date registered
3/02/2012
Date last updated
30/07/2019
Titles & IDs
Public title
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
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Scientific title
A SINGLE-ARM OPEN-LABEL INTERNATIONAL MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF SUNITINIB MALATE (SU011248, SUTENT (REGISTERED)) IN PATIENTS WITH PROGRESSIVE ADVANCED METASTATIC WELL-DIFFERENTIATED UNRESECTABLE PANCREATIC NEUROENDOCRINE TUMORS
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Secondary ID [1]
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2011-004363-74
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Secondary ID [2]
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A6181202
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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:
Well-differentiated Pancreatic Neuroendocrine Tumor
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Condition category
Condition code
Cancer
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Neuroendocrine tumour (NET)
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Cancer
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Pancreatic
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Metabolic and Endocrine
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Other endocrine disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - sunitinib
Experimental: sunitinib -
Treatment: Drugs: sunitinib
Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.
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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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Progression-Free Survival (PFS): Investigator Assessment
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Assessment method [1]
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Investigator assessed PFS was defined as the time (in months) from the date of enrollment in study to the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0 criteria was defined as: greater than or equal to (>=) 20 percent increase in sum of longest diameter (LD) of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
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Timepoint [1]
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Baseline until disease progression or death due to any cause (up to 1226 days)
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Secondary outcome [1]
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Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment
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Assessment method [1]
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IRR assessed PFS was defined as the time (in months) from the date of enrollment in study until the date of first documented objective tumor progression or death (due to any cause), whichever occurs first. PFS calculated as (first event date minus date of enrollment plus 1)/30.4. If progression or death was not observed, the participant was censored at the date of the participant's last progression-free tumor assessment prior to the study cut-off date. Progression as per RECIST 1.0 criteria was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
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Timepoint [1]
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Baseline until disease progression or death due to any cause (up to 1226 days)
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Secondary outcome [2]
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Time to Tumor Progression (TTP): Investigator Assessment
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Assessment method [2]
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Investigator assessed TTP was defined as the time (in months) from the date of enrollment in study until the date of first documentation of objective tumor progression. TTP calculated as (first event date minus date of enrollment plus 1)/30.4. Progression as per RECIST 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. The analysis was performed by Kaplan-Meier method.
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Timepoint [2]
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Baseline until first documented tumor progression (up to 1226 days)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time (in months) from date of enrollment in study to the date of death due to any cause. If death was not observed, the participant was censored at the earliest of the last date the participant was known to be alive or the end of study. The analysis was performed by Kaplan-Meier method.
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Timepoint [3]
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Baseline until death or end of study (up to 1939 days)
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Secondary outcome [4]
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Percentage of Participants With Objective Response (OR): Investigator Assessment
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Assessment method [4]
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Investigator assessed OR in participants was defined as having a complete response (CR) or partial response (PR) according to RECIST 1.0 and sustained for at least 4 weeks. CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Percentage of participants with investigator assessed OR were reported.
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Timepoint [4]
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Baseline until disease progression or death due to any cause (up to 1226 days)
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Secondary outcome [5]
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Duration of Response (DOR): Investigator Assessment
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Assessment method [5]
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Investigator assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR), that was subsequently confirmed, to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to RECIST 1.0, CR was defined as disappearance of all target and non-target lesions. PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD. Progression as per RECIST version 1.0 was defined as >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
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Timepoint [5]
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Baseline until disease progression or death due to any cause (up to 1226 days)
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Secondary outcome [6]
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Time to Tumor Response (TTR): Investigator Assessment
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Assessment method [6]
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Investigator assessed TTR was defined as the time (in months) from date of enrollment in study until date of first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. As per RECIST 1.0, CR was defined as disappearance of all target and non-target lesions and PR was defined as >=30 percent decrease in the sum of the LD of the target lesions taking as a reference the baseline sum LD.
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Timepoint [6]
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Baseline until first documented objective tumor response (up to 1226 days)
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Secondary outcome [7]
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Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment
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Assessment method [7]
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IRR assessed OR in participants was defined as having a CR or PR according to Choi criteria and sustained for at least 4 weeks. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on Computed tomography (CT) with no new lesions and no obvious progression of non-measurable disease. Percentage of participants with objective response were reported in this outcome measure.
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Timepoint [7]
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Baseline until disease progression or death due to any cause (up to 1226 days)
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Secondary outcome [8]
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Duration of Response (DOR): Independent Radiological Review (IRR) Assessment
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Assessment method [8]
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IRR assessed DOR was defined as the time (in months) from the date of first documented objective tumor response (CR or PR) that was subsequently confirmed to the first documented objective tumor progression or death due to any cause, whichever occurred first. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.
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Timepoint [8]
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Baseline until disease progression or death due to any cause (up to 1226 days)
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Secondary outcome [9]
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Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment
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Assessment method [9]
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IRR assessed TTR was defined as the time (in months) from date of enrollment in study until first documentation of objective tumor response (CR or PR) that was subsequently confirmed. TTR was calculated as (first response date minus the date of enrollment plus 1) divided by 30.4. According to Choi criteria, CR was defined as disappearance of all target and non-target lesions and no new lesions. PR was defined as a decrease of >=10 percent in tumor size or a decrease in tumor density (HU) of 15 percent or more on CT with no new lesions and no obvious progression of non-measurable disease.
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Timepoint [9]
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Baseline until first documented objective tumor response (up to 1226 days)
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Secondary outcome [10]
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Percentage of Participants With Chromogranin A (CgA) Response
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Assessment method [10]
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CgA response in participants was defined as having confirmed CgA CR or CgA PR, relative to the population with an elevated baseline CgA value in the blood. CgA CR was defined as decrease from a high baseline value of CgA in the blood to one that fell within the normal range. CgA PR was defined as a decrease of greater than or equal to 50 percent from a high baseline value of CgA. Normal baseline value of CgA in blood was 39.0 ng/mL. Confirmed responses were those that persisted for at least 4 weeks after initial documentation of response. Blood levels of CgA were assessed and percentage of participants with CgA response were reported.
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Timepoint [10]
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Baseline until CgA response or death due to any cause (up to 1226 days)
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Secondary outcome [11]
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Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
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Assessment method [11]
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EORTC QLQ-C30 is a cancer-specific instrument with 30 questions to assess the participant quality of life. First 28 questions used for evaluating 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, pain) and other single items (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties). Each question was assessed on 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); high score represented high level of symptomatology/problem. Last 2 questions used for evaluating global health status (GHS)/quality of life. Each question was assessed on 7-point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning.
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Timepoint [11]
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Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
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Secondary outcome [12]
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Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Gastrointestinal Related Neuroendocrine Tumours-21 (EORTC QLQ-GI NET 21)
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Assessment method [12]
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EORTC QLQ-GI-NET 21 was a 21-item questionnaire. These 21 questions assesses endocrine symptoms, gastrointestinal (G.I.) symptoms, treatment related symptoms, social functioning, disease related worries, muscle/bone pain, sexual function, information/communication function and body image. Each item was answered on a 4-point scale: 1 =not at all, 2 =a little, 3 =quite a bit, 4 =very much; where higher scores indicated more severe symptoms/problems. Scores averaged, transformed to 0-100 scale; higher score=more severe symptoms.
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Timepoint [12]
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Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
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Secondary outcome [13]
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Plasma Concentration of Soluble Protein Biomarker (sKIT)
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Assessment method [13]
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Timepoint [13]
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Pre-dose on Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 3 and every 2 cycles thereafter (Cycle 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43), End of Treatment (up to maximum duration of 1226 days)
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Secondary outcome [14]
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Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
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Assessment method [14]
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Ctrough is the minimum observed plasma concentration of drug. SU012662 is the metabolite of sunitinib.
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Timepoint [14]
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Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
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Secondary outcome [15]
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Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
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Assessment method [15]
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Dose-corrected plasma trough concentration is calculated as: trough plasma concentration*(intended dose divided by actual dose). Intended dose was defined as the starting dose in the study and actual dose was defined as the last dose which the participant had received. SU012662 is the metabolite of sunitinib.
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Timepoint [15]
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Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
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Secondary outcome [16]
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Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662
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Assessment method [16]
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Area under the plasma concentration-time profile from time zero (pre-dose) to 24 hours post-dose. SU012662 is the metabolite of sunitinib.
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Timepoint [16]
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Pre-dose (0 hour) and at multiple time points (up to 24 hours) post dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
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Secondary outcome [17]
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Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662
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Assessment method [17]
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Clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
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Timepoint [17]
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Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
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Secondary outcome [18]
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Half Maximal Effective Concentration (EC50) of Sunitinib
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Assessment method [18]
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Concentration of sunitinib in plasma at which 50 percent of the maximum effect was observed.
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Timepoint [18]
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Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
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Secondary outcome [19]
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Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [19]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
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Timepoint [19]
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Baseline up to 1939 days
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Secondary outcome [20]
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Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [20]
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Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1939 days that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
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Timepoint [20]
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Baseline up to 1939 days
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Secondary outcome [21]
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Number of Participants With Adverse Events (AEs) According to Severity
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Assessment method [21]
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.
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Timepoint [21]
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Baseline up to 1939 days
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Secondary outcome [22]
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Number of Participants With Clinically Significant Laboratory Abnormalities
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Assessment method [22]
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Following parameters were analyzed for laboratory examination: hematology (hemoglobin, red blood cell count, platelet count, white blood cell count, total neutrophils, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine); electrolytes (sodium, potassium, chloride, calcium, magnesium, phosphate); urinalysis (urine protein), miscellaneous (pregnancy test, Chromogranin A). Clinically significant laboratory abnormalities were identified by the Investigator.
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Timepoint [22]
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Baseline up to 1939 days
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Secondary outcome [23]
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Number of Participants With Change From Baseline in Vital Signs Abnormalities
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Assessment method [23]
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Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, body temperature and heart rate.
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Timepoint [23]
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Baseline up to 1939 days
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Secondary outcome [24]
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Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)
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Assessment method [24]
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Timepoint [24]
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Baseline up to 1939 days
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Secondary outcome [25]
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Number of Participants With Change From Baseline in Physical Examinations Findings
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Assessment method [25]
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Physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, extremities, thyroid and others.
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Timepoint [25]
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Baseline up to 1939 days
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Secondary outcome [26]
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Number of Participants With Change From Baseline in Body Weight
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Assessment method [26]
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Participants with increase of >=5 percent and decrease of >=5 percent from baseline in body weight were reported in this outcome measure.
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Timepoint [26]
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Baseline up to 1939 days
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Secondary outcome [27]
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Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
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Assessment method [27]
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ECOG-PS performance status is used to assess how the disease affects the daily living abilities of the participant. It was measured on 6-point scale ranging from 0-5, where 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory/able to carry out light or sedentary work; 2= ambulatory for more than 50 percent of waking hours and capable of all self-care but unable to carry out any work activities; 3= capable of limited self-care, confined to bed or chair >50 percent of waking hours; 4= completely disabled, not capable of any self-care, totally confined to bed or chair; 5= dead. A higher score indicated greater functional impairment. Only those ECOG-PS categories, in which at least one participant had data at any indicated time point were reported in this outcome measure. Not reported (NR) category included participants with unavailable ECOG performance status.
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Timepoint [27]
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Day 1 of Cycle 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, End of treatment (up to maximum duration of 1226 days)
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Eligibility
Key inclusion criteria
- Histologically or cytologically proven diagnosis of well-differentiated pancreatic
neuroendocrine tumor (according to World Health Organization [WHO 2000]
classification).
- Disease progression within 12 months prior to study enrollment.
- Disease that is not amenable to surgery, radiation, or combined modality therapy with
curative intent.
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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
- Patients with poorly differentiated pancreatic neuroendocrine tumors (according to WHO
2000 classification).
- Prior treatment with any tyrosine kinase inhibitors, anti vascular endothelial growth
factor (VEGF) angiogenesis inhibitors, non VEGF targeted angiogenesis inhibitors, or
mammalian target of rapamycin (mTOR) inhibitors.
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Study design
Purpose of the study
Other
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Allocation to intervention
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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
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Other design features
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Phase
Phase 4
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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
6/06/2012
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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
26/07/2018
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Sample size
Target
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Accrual to date
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Final
106
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Barwon Health - University Hospital Geelong - Geelong
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Recruitment postcode(s) [1]
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3220 - Geelong
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
New York
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Country [3]
0
0
Belgium
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State/province [3]
0
0
Brussels Gewest
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Country [4]
0
0
China
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State/province [4]
0
0
Beijing
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Country [5]
0
0
China
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State/province [5]
0
0
Jiangsu
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Country [6]
0
0
China
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State/province [6]
0
0
Sichuan
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Country [7]
0
0
China
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State/province [7]
0
0
Shanghai
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Country [8]
0
0
Czechia
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State/province [8]
0
0
Brno
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Country [9]
0
0
Czechia
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State/province [9]
0
0
Praha 2
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Country [10]
0
0
France
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State/province [10]
0
0
Clichy Cedex
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Country [11]
0
0
Hungary
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State/province [11]
0
0
Budapest
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Country [12]
0
0
India
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State/province [12]
0
0
Maharashtra
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Country [13]
0
0
Italy
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State/province [13]
0
0
Milano
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Country [14]
0
0
Japan
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State/province [14]
0
0
Fukuoka
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Country [15]
0
0
Japan
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State/province [15]
0
0
Tokyo
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Country [16]
0
0
Norway
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State/province [16]
0
0
Oslo
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Country [17]
0
0
Romania
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State/province [17]
0
0
Dolj
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Country [18]
0
0
Romania
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State/province [18]
0
0
Bucuresti
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Country [19]
0
0
Slovakia
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State/province [19]
0
0
Bratislava
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Country [20]
0
0
South Africa
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State/province [20]
0
0
Gauteng
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Country [21]
0
0
Spain
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State/province [21]
0
0
Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to confirm the safety and efficacy of sunitinib in subjects with
unresectable pancreatic neuroendocrine tumors.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01525550
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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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0
Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
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0
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Address
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0
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01525550
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