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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00428220




Registration number
NCT00428220
Ethics application status
Date submitted
26/01/2007
Date registered
29/01/2007
Date last updated
27/06/2019

Titles & IDs
Public title
A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
Scientific title
An Open-label Sunitinib Malate (su011248) Continuation Protocol For Patients Who Have Completed A Prior Sunitinib Study And Are Judged By The Investigator To Have The Potential To Benefit From Sunitinib Treatment
Secondary ID [1] 0 0
2006-006538-16
Secondary ID [2] 0 0
A6181114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Advanced Breast Cancer 0 0
Metastatic Castration Resistant Prostate Cancer 0 0
Metastatic Renal Cell Cancer 0 0
Non-Small Cell Lung Cancer 0 0
Thyroid Cancer 0 0
Advanced/Metastatic Non-Small Cell Lung Cancer 0 0
Advanced Gastric Cancer 0 0
Gastrointestinal Stromal Tumor 0 0
Hepatocellular Carcinoma 0 0
Pancreatic Islet Cell Carcinoma 0 0
Pancreatic Neuroendocrine Tumor 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
Breast
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Cancer 0 0 0 0
Liver
Cancer 0 0 0 0
Thyroid
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
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: A - Sunitinib will be administered in a continuous daily dose (oral, once per day). Starting dose will be 37.5 mg daily unless the patient was on a different dose (25 mg or 50 mg daily) on the previous trial. In that case, they will begin treatment on this study at the same dose used at the end of the previous study.
The protocol now allows for patients on dosing regimens other than only continuous dosing (e.g. 4/2, etc.) to be enrolled if eligible.


Treatment: Drugs: sunitinib
sunitinib

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

Outcomes
Primary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (AEs) (All Causalities) - Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Timepoint [1] 0 0
From first day of treatment on the current study up to 28 days post the last dose of study treatment
Primary outcome [2] 0 0
Number of Participants With Treatment-emergent AEs (Treatment-Related) - Assessment of AEs included type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 3.0, timing, seriousness, and relatedness; and laboratory abnormalities.
Timepoint [2] 0 0
From first day of treatment on the current study up to 28 days post the last dose of study treatment

Eligibility
Key inclusion criteria
- Must have ended treatment from one of the following sunitinib studies: A6181030,
A6181064, A6181078, A6181087, A6181094, A6181107, A6181108, A6181110, A6181111,
A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer sponsored sunitinib
studies may be included in the future.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- See inclusion criteria

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [2] 0 0
Royal Adelaide Hospital, Department of Medical Oncology - Adelaide
Recruitment hospital [3] 0 0
Austin Health - Heidelberg
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [5] 0 0
Mount Medical Centre - Perth
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
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
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Argentina
State/province [9] 0 0
Rio Negro
Country [10] 0 0
Argentina
State/province [10] 0 0
Santa Fé
Country [11] 0 0
Argentina
State/province [11] 0 0
Nueva Cordoba
Country [12] 0 0
Argentina
State/province [12] 0 0
San Miguel de Tucuman
Country [13] 0 0
Belgium
State/province [13] 0 0
Bruxelles
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Liege
Country [16] 0 0
Belgium
State/province [16] 0 0
Sint-Niklaas
Country [17] 0 0
Belgium
State/province [17] 0 0
Wilrijk
Country [18] 0 0
Brazil
State/province [18] 0 0
RS
Country [19] 0 0
Brazil
State/province [19] 0 0
SP
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
Nova Scotia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Colombia
State/province [24] 0 0
Anquioquia
Country [25] 0 0
Colombia
State/province [25] 0 0
Antioquia
Country [26] 0 0
France
State/province [26] 0 0
Cedex 02
Country [27] 0 0
France
State/province [27] 0 0
Cedex
Country [28] 0 0
France
State/province [28] 0 0
Besancon
Country [29] 0 0
France
State/province [29] 0 0
Bordeaux Cedex
Country [30] 0 0
France
State/province [30] 0 0
Clermont Ferrand
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Lyon Cedex 03
Country [33] 0 0
France
State/province [33] 0 0
Lyon
Country [34] 0 0
France
State/province [34] 0 0
Marseille Cedex 5
Country [35] 0 0
France
State/province [35] 0 0
Neuilly Sur Seine
Country [36] 0 0
France
State/province [36] 0 0
Paris
Country [37] 0 0
France
State/province [37] 0 0
Rennes Cedex
Country [38] 0 0
Germany
State/province [38] 0 0
Bad Berka
Country [39] 0 0
Germany
State/province [39] 0 0
Berlin
Country [40] 0 0
Germany
State/province [40] 0 0
Jena
Country [41] 0 0
Germany
State/province [41] 0 0
Kiel
Country [42] 0 0
Germany
State/province [42] 0 0
Luebeck
Country [43] 0 0
Germany
State/province [43] 0 0
Marburg
Country [44] 0 0
Germany
State/province [44] 0 0
Meiningen
Country [45] 0 0
Germany
State/province [45] 0 0
Muenchen
Country [46] 0 0
Hong Kong
State/province [46] 0 0
New Territories
Country [47] 0 0
Hong Kong
State/province [47] 0 0
Hong Kong
Country [48] 0 0
Hong Kong
State/province [48] 0 0
Kowloon
Country [49] 0 0
Hong Kong
State/province [49] 0 0
Tuen Mun, New Territories
Country [50] 0 0
Hong Kong
State/province [50] 0 0
Wan Chai,
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Gyeonggi-do
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Republic Of Korea
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Daegu
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Seoul
Country [55] 0 0
Mexico
State/province [55] 0 0
Nuevo Leon
Country [56] 0 0
Mexico
State/province [56] 0 0
Chihuahua
Country [57] 0 0
Philippines
State/province [57] 0 0
Quezon City, Metro Manila
Country [58] 0 0
Singapore
State/province [58] 0 0
Singapore
Country [59] 0 0
Spain
State/province [59] 0 0
Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
La Coruña
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taoyuan
Country [63] 0 0
Taiwan
State/province [63] 0 0
Changhua
Country [64] 0 0
Taiwan
State/province [64] 0 0
Kaohsiung
Country [65] 0 0
Taiwan
State/province [65] 0 0
Liouying Township, Tainan,
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taichung
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taipei
Country [68] 0 0
Taiwan
State/province [68] 0 0
YungKang City, Tainan
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Merseyside
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Glasgow
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Leeds
Country [72] 0 0
United Kingdom
State/province [72] 0 0
London
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Manchester
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Nottingham

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a study using sunitinib for patients ending treatment on a previous sunitinib malate
protocol to continue to receive sunitinib. The patient must have been enrolled in one of the
following studies: A6181030, A6181064, A6181078, A6181087, A6181094, A6181107, A6181108,
A6181110, A6181111, A6181112, A6181113, A6181120, A6181126 and A6181170. Other Pfizer
sponsored sunitinib studies may be included in the future.
Trial website
https://clinicaltrials.gov/show/NCT00428220
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

Summary results
Other publications