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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/NCT00428597
Registration number
NCT00428597
Ethics application status
Date submitted
29/01/2007
Date registered
30/01/2007
Date last updated
11/10/2010
Titles & IDs
Public title
A Study Of Sunitinib Compared To Placebo For Patients With Advanced Pancreatic Islet Cell Tumors
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Scientific title
A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors
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Secondary ID [1]
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A6181111
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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:
Carcinoma, Islet Cell
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0
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Carcinoma, Pancreas
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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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0
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Kidney
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Cancer
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0
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Pancreatic
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Metabolic and Endocrine
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0
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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 malate
Treatment: Drugs - Placebo
Experimental: A -
Placebo Comparator: B -
Treatment: Drugs: sunitinib malate
sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
Dose may be decreased to 25 mg daily in case of adverse events.
It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination.
Treatment: Drugs: Placebo
Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.
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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)
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Assessment method [1]
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Time from randomization to first progression of disease (PD) or death for any reason in the absence of documented PD. PFS was calculated as (first event date minus first randomization date +1) divided by 30.4.
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Timepoint [1]
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From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death
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Secondary outcome [1]
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Number of Subjects With Objective Response
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Assessment method [1]
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Objective response = subjects with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) for at least 4 weeks, confirmed by repeat tumor assessments. A CR was defined as the disappearance of all target lesions. A PR was defined as a > = 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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Timepoint [1]
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0
From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
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Secondary outcome [2]
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Duration of Response (DR)
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Assessment method [2]
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Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated as (the date of the first documentation of objective tumor progression or death due to any cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4.
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Timepoint [2]
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From start of treatment through Day 1 of Week 5, 9, and every 8 weeks thereafter until disease progression or death due to any cause
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Secondary outcome [3]
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Time-to-Tumor Response (TTR)
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Assessment method [3]
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Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed.
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Timepoint [3]
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From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Time in months from time of randomization to date of death due to any cause. The median number of months is provided; however, the study was terminated early. OS data was not mature by the time of analysis. Median OS time cannot be accurately estimated by Kaplan-Meier method for either treatment arm.
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Timepoint [4]
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From start of study treatment up to 22 months
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Secondary outcome [5]
0
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European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
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Assessment method [5]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [5]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [6]
0
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EORTC QLQ-C30 - Cognitive Functioning Subscale
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Assessment method [6]
0
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [6]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [7]
0
0
EORTC QLQ-C30 - Emotional Functioning Subscale
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Assessment method [7]
0
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [7]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [8]
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EORTC QLQ-C30 - Physical Functioning Subscale
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Assessment method [8]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [8]
0
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Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [9]
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EORTC QLQ-C30 - Role Functioning Subscale
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Assessment method [9]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [9]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [10]
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EORTC QLQ-C30 - Social Functioning Subscale
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Assessment method [10]
0
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [10]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [11]
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EORTC QLQ-C30 - Appetite Loss Subscale
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Assessment method [11]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [11]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [12]
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EORTC QLQ-C30 - Constipation Subscale
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Assessment method [12]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [12]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [13]
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EORTC QLQ-C30 - Diarrhea Subscale
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Assessment method [13]
0
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [13]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [14]
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EORTC QLQ-C30 - Dyspnea Subscale
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Assessment method [14]
0
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [14]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [15]
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EORTC QLQ-C30 - Fatigue Subscale
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Assessment method [15]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [15]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [16]
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EORTC QLQ-C30 - Financial Difficulties Subscale
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Assessment method [16]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [16]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [17]
0
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EORTC QLQ-C30 - Insomnia Subscale
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Assessment method [17]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [17]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [18]
0
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EORTC QLQ-C30 - Nausea and Vomiting Subscale
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Assessment method [18]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [18]
0
0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Secondary outcome [19]
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EORTC QLQ-C30 - Pain Subscale
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Assessment method [19]
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EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
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Timepoint [19]
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Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
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Eligibility
Key inclusion criteria
- Well-differentiated advanced/metastatic pancreatic islet cell tumor
- Tumor has shown progression within the past year.
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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
- Current treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or
investigational anticancer agent other than somatostatin analogues
- Prior treatment with any tyrosine kinase inhibitors or anti-VEGF[Vascular endothelial
growth factor] angiogenic inhibitors.
- Prior treatment with non-VEGF-targeted angiogenic inhibitors is permitted
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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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
1/06/2007
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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
1/04/2009
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Sample size
Target
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Accrual to date
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Final
171
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Perth
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Recruitment postcode(s) [1]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
0
0
United States of America
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State/province [2]
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Iowa
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Country [3]
0
0
United States of America
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State/province [3]
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Massachusetts
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Country [4]
0
0
United States of America
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State/province [4]
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Missouri
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Country [5]
0
0
United States of America
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State/province [5]
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Texas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Virginia
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Country [7]
0
0
Belgium
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State/province [7]
0
0
Bruxelles
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Country [8]
0
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Belgium
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State/province [8]
0
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Leuven
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Country [9]
0
0
Canada
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State/province [9]
0
0
British Columbia
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Country [10]
0
0
Canada
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State/province [10]
0
0
Nova Scotia
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Country [11]
0
0
Canada
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State/province [11]
0
0
Ontario
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Country [12]
0
0
Canada
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State/province [12]
0
0
Quebec
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Country [13]
0
0
France
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State/province [13]
0
0
Be1 05677
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Country [14]
0
0
France
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State/province [14]
0
0
Cedex
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Country [15]
0
0
France
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State/province [15]
0
0
Bordeaux
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Country [16]
0
0
France
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State/province [16]
0
0
Clichy Cedex
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Country [17]
0
0
France
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State/province [17]
0
0
Lyon
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Country [18]
0
0
France
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State/province [18]
0
0
Marseille
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Country [19]
0
0
France
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State/province [19]
0
0
Rennes Cedex
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Country [20]
0
0
Germany
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State/province [20]
0
0
Bad Berka
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Country [21]
0
0
Germany
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State/province [21]
0
0
Berlin
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Country [22]
0
0
Germany
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State/province [22]
0
0
Heidelberg
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Country [23]
0
0
Germany
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State/province [23]
0
0
Luebeck
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Country [24]
0
0
Germany
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State/province [24]
0
0
Marburg
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Country [25]
0
0
Germany
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State/province [25]
0
0
Ulm
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Country [26]
0
0
Italy
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State/province [26]
0
0
Cremona
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Country [27]
0
0
Italy
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State/province [27]
0
0
Milano
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Country [28]
0
0
Italy
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State/province [28]
0
0
Rozzano (MI)
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Country [29]
0
0
Korea, Republic of
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State/province [29]
0
0
Seoul
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Country [30]
0
0
Spain
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State/province [30]
0
0
Barcelona
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Country [31]
0
0
Spain
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State/province [31]
0
0
Madrid
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Country [32]
0
0
Taiwan
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State/province [32]
0
0
Taoyuan
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Country [33]
0
0
Taiwan
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State/province [33]
0
0
Taipei
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Country [34]
0
0
United Kingdom
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State/province [34]
0
0
Leeds
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Country [35]
0
0
United Kingdom
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State/province [35]
0
0
Liverpool
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Country [36]
0
0
United Kingdom
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State/province [36]
0
0
Manchester
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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
This study randomized patients with advanced pancreatic islet cell tumors to receive either
sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib
daily, those randomized to placebo received a tablet that looked similar but had no active
drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or
placebo. Patients were followed to determine the status and size of their tumors, survival,
quality of life and safety of the drug.
The study was designed to detect a 50% improvement in median PFS[Progression Free Survival]
with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130
events had occurred, and the final analysis was to be conducted when 260 events had occurred.
Study A6181111 was stopped early during the enrollment period because of a clear and
clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended
by the DMC [Data Monitoring Committee]. The actual number of subjects enrolled was 171 and
the actual number of PFS events recorded was 81 PFS events. The decision to terminate the
study was not based on safety concerns related to sunitinib administration.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00428597
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
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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
0
0
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Address
0
0
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00428597
Download to PDF