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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01525550




Registration number
NCT01525550
Ethics application status
Date submitted
13/01/2012
Date registered
3/02/2012

Titles & IDs
Public title
A Study Of The Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors
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
Secondary ID [1] 0 0
2011-004363-74
Secondary ID [2] 0 0
A6181202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Well-differentiated Pancreatic Neuroendocrine Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
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

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

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS): Investigator Assessment
Timepoint [1] 0 0
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS): Independent Radiological Review (IRR) Assessment
Timepoint [1] 0 0
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcome [2] 0 0
Time to Tumor Progression (TTP): Investigator Assessment
Timepoint [2] 0 0
Baseline until first documented tumor progression (up to 1226 days)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline until death or end of study (up to 1939 days)
Secondary outcome [4] 0 0
Percentage of Participants With Objective Response (OR): Investigator Assessment
Timepoint [4] 0 0
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcome [5] 0 0
Duration of Response (DOR): Investigator Assessment
Timepoint [5] 0 0
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcome [6] 0 0
Time to Tumor Response (TTR): Investigator Assessment
Timepoint [6] 0 0
Baseline until first documented objective tumor response (up to 1226 days)
Secondary outcome [7] 0 0
Percentage of Participants With Objective Response (OR): Independent Radiological Review (IRR) Assessment
Timepoint [7] 0 0
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcome [8] 0 0
Duration of Response (DOR): Independent Radiological Review (IRR) Assessment
Timepoint [8] 0 0
Baseline until disease progression or death due to any cause (up to 1226 days)
Secondary outcome [9] 0 0
Time to Tumor Response (TTR): Independent Radiological Review (IRR) Assessment
Timepoint [9] 0 0
Baseline until first documented objective tumor response (up to 1226 days)
Secondary outcome [10] 0 0
Percentage of Participants With Chromogranin A (CgA) Response
Timepoint [10] 0 0
Baseline until CgA response or death due to any cause (up to 1226 days)
Secondary outcome [11] 0 0
Quality of Life Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Timepoint [11] 0 0
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)
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
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)
Secondary outcome [13] 0 0
Plasma Concentration of Soluble Protein Biomarker (sKIT)
Timepoint [13] 0 0
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)
Secondary outcome [14] 0 0
Minimum Observed Plasma Concentration (Ctrough) of Sunitinib and Its Metabolite SU012662
Timepoint [14] 0 0
Pre-dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
Secondary outcome [15] 0 0
Dose-Corrected Trough Plasma Concentration of Sunitinib and Its Metabolite SU012662
Timepoint [15] 0 0
Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5
Secondary outcome [16] 0 0
Area Under the Curve (AUC24) of Sunitinib and Its Metabolite SU012662
Timepoint [16] 0 0
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)
Secondary outcome [17] 0 0
Oral Clearance (CL/F) of Sunitinib and Its Metabolite SU012662
Timepoint [17] 0 0
Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
Secondary outcome [18] 0 0
Half Maximal Effective Concentration (EC50) of Sunitinib
Timepoint [18] 0 0
Pre dose on Day 15 of Cycle 1, Day 1 of Cycle 2, 3 and 5 (each cycle 28 days)
Secondary outcome [19] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [19] 0 0
Baseline up to 1939 days
Secondary outcome [20] 0 0
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [20] 0 0
Baseline up to 1939 days
Secondary outcome [21] 0 0
Number of Participants With Adverse Events (AEs) According to Severity
Timepoint [21] 0 0
Baseline up to 1939 days
Secondary outcome [22] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities
Timepoint [22] 0 0
Baseline up to 1939 days
Secondary outcome [23] 0 0
Number of Participants With Change From Baseline in Vital Signs Abnormalities
Timepoint [23] 0 0
Baseline up to 1939 days
Secondary outcome [24] 0 0
Number of Participants With Increase From Baseline in Corrected QT Interval (QTc)
Timepoint [24] 0 0
Baseline up to 1939 days
Secondary outcome [25] 0 0
Number of Participants With Change From Baseline in Physical Examinations Findings
Timepoint [25] 0 0
Baseline up to 1939 days
Secondary outcome [26] 0 0
Number of Participants With Change From Baseline in Body Weight
Timepoint [26] 0 0
Baseline up to 1939 days
Secondary outcome [27] 0 0
Number of Participants With Eastern Co-operative Oncology Group Performance Status (ECOG-PS)
Timepoint [27] 0 0
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)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2018
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Barwon Health - University Hospital Geelong - Geelong
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
Belgium
State/province [3] 0 0
Brussels Gewest
Country [4] 0 0
China
State/province [4] 0 0
Beijing
Country [5] 0 0
China
State/province [5] 0 0
Jiangsu
Country [6] 0 0
China
State/province [6] 0 0
Sichuan
Country [7] 0 0
China
State/province [7] 0 0
Shanghai
Country [8] 0 0
Czechia
State/province [8] 0 0
Brno
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 2
Country [10] 0 0
France
State/province [10] 0 0
Clichy Cedex
Country [11] 0 0
Hungary
State/province [11] 0 0
Budapest
Country [12] 0 0
India
State/province [12] 0 0
Maharashtra
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Japan
State/province [14] 0 0
Fukuoka
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
Norway
State/province [16] 0 0
Oslo
Country [17] 0 0
Romania
State/province [17] 0 0
Dolj
Country [18] 0 0
Romania
State/province [18] 0 0
Bucuresti
Country [19] 0 0
Slovakia
State/province [19] 0 0
Bratislava
Country [20] 0 0
South Africa
State/province [20] 0 0
Gauteng
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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/NCT01525550