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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
A6181111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Islet Cell 0 0
Carcinoma, Pancreas 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Pancreatic
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
From time of randomization through Day 1 of Week 5, Week 9, and then every 8 weeks thereafter until disease progression or death
Secondary outcome [1] 0 0
Number of Subjects With Objective Response
Timepoint [1] 0 0
From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
Secondary outcome [2] 0 0
Duration of Response (DR)
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Time-to-Tumor Response (TTR)
Timepoint [3] 0 0
From time of randomization through Day 1 of Week 5, 9, and every 8 weeks thereafter
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
From start of study treatment up to 22 months
Secondary outcome [5] 0 0
European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire (EORTC QLQ-C30) - Global Quality of Life (QoL) Subscale
Timepoint [5] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [6] 0 0
EORTC QLQ-C30 - Cognitive Functioning Subscale
Timepoint [6] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [7] 0 0
EORTC QLQ-C30 - Emotional Functioning Subscale
Timepoint [7] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [8] 0 0
EORTC QLQ-C30 - Physical Functioning Subscale
Timepoint [8] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [9] 0 0
EORTC QLQ-C30 - Role Functioning Subscale
Timepoint [9] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [10] 0 0
EORTC QLQ-C30 - Social Functioning Subscale
Timepoint [10] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [11] 0 0
EORTC QLQ-C30 - Appetite Loss Subscale
Timepoint [11] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [12] 0 0
EORTC QLQ-C30 - Constipation Subscale
Timepoint [12] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [13] 0 0
EORTC QLQ-C30 - Diarrhea Subscale
Timepoint [13] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [14] 0 0
EORTC QLQ-C30 - Dyspnea Subscale
Timepoint [14] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [15] 0 0
EORTC QLQ-C30 - Fatigue Subscale
Timepoint [15] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [16] 0 0
EORTC QLQ-C30 - Financial Difficulties Subscale
Timepoint [16] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [17] 0 0
EORTC QLQ-C30 - Insomnia Subscale
Timepoint [17] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [18] 0 0
EORTC QLQ-C30 - Nausea and Vomiting Subscale
Timepoint [18] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal
Secondary outcome [19] 0 0
EORTC QLQ-C30 - Pain Subscale
Timepoint [19] 0 0
Day 1 and every 4 weeks thereafter (Day 1 of each 4-week cycle) and at end of treatment/withdrawal

Eligibility
Key inclusion criteria
* Well-differentiated advanced/metastatic pancreatic islet cell tumor
* Tumor has shown progression within the past year.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
171
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Nova Scotia
Country [11] 0 0
Canada
State/province [11] 0 0
Ontario
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
France
State/province [13] 0 0
Be1 05677
Country [14] 0 0
France
State/province [14] 0 0
Cedex
Country [15] 0 0
France
State/province [15] 0 0
Bordeaux
Country [16] 0 0
France
State/province [16] 0 0
Clichy Cedex
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
France
State/province [18] 0 0
Marseille
Country [19] 0 0
France
State/province [19] 0 0
Rennes Cedex
Country [20] 0 0
Germany
State/province [20] 0 0
Bad Berka
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Heidelberg
Country [23] 0 0
Germany
State/province [23] 0 0
Luebeck
Country [24] 0 0
Germany
State/province [24] 0 0
Marburg
Country [25] 0 0
Germany
State/province [25] 0 0
Ulm
Country [26] 0 0
Italy
State/province [26] 0 0
Cremona
Country [27] 0 0
Italy
State/province [27] 0 0
Milano
Country [28] 0 0
Italy
State/province [28] 0 0
Rozzano (MI)
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Madrid
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taoyuan
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Leeds
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Liverpool
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00428597