A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.

NCT00428220

Last updated date
Study Location
Emory University, Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer, Advanced Breast Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Renal Cell Cancer, Non-Small Cell Lung Cancer, Thyroid Cancer, Advanced/Metastatic Non-Small Cell Lung Cancer, Advanced Gastric Cancer,
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- See inclusion criteria

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Metastatic Breast Cancer, Advanced Breast Cancer, Metastatic Castration Resistant Prostate Cancer, Metastatic Renal Cell Cancer, Non-Small Cell Lung Cancer, Thyroid Cancer, Advanced/Metastatic Non-Small Cell Lung Cancer, Advanced Gastric Cancer,A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
NCT00428220
  1. Atlanta, Georgia
  2. Atlanta, Georgia
  3. Atlanta, Georgia
  4. Maywood, Illinois
  5. Iowa City, Iowa
  6. Creve Coeur, Missouri
  7. Saint Louis, Missouri
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  34. Sao Paulo, SP
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  37. Halifax, Nova Scotia
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  40. London, Ontario
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  42. Montreal, Quebec
  43. Montreal, Quebec
  44. Medellin, Anquioquia
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  46. Medellin, Antioquia
  47. Nice, Cedex 02
  48. Clichy Cedex, Cedex
  49. Paris, Cedex
  50. Besancon,
  51. Bordeaux Cedex,
  52. Clermont Ferrand,
  53. Lille,
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  55. Lyon Cedex 03,
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  62. Berlin,
  63. Jena,
  64. Kiel,
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  69. Muenchen,
  70. Tuen Mun, New Territories
  71. Hong Kong,
  72. Hong Kong,
  73. Kowloon,
  74. Tuen Mun, New Territories,
  75. Wan Chai,,
  76. Goyang-si, Gyeonggi-do
  77. Seongnam-si, Gyeonggi-do
  78. Seoul, Republic Of Korea
  79. Seoul, Republic Of Korea
  80. Daegu,
  81. Seoul,
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  96. Changhua,
  97. Kaohsiung,
  98. Liouying Township, Tainan,,
  99. Taichung,
  100. Taipei,
  101. Taipei,
  102. Taipei,
  103. YungKang City, Tainan,
  104. Liverpool, Merseyside
  105. Glasgow,
  106. Glasgow,
  107. Leeds,
  108. Leeds,
  109. London,
  110. London,
  111. Manchester,
  112. Manchester,
  113. Nottingham,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Continuation Study Using Sunitinib Malate For Patients Leaving Treatment On A Previous Sunitinib Study.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Advanced Breast Cancer
  • Metastatic Castration Resistant Prostate Cancer
  • Metastatic Renal Cell Cancer
  • Non-Small Cell Lung Cancer
  • Thyroid Cancer
  • Advanced/Metastatic Non-Small Cell Lung Cancer
  • Advanced Gastric Cancer
  • Gastrointestinal Stromal Tumor
  • Hepatocellular Carcinoma
  • Pancreatic Islet Cell Carcinoma
  • Pancreatic Neuroendocrine Tumor
Intervention  ICMJE Drug: sunitinib
sunitinib
Study Arms  ICMJE 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.

Intervention: Drug: sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2019)
223
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  • See inclusion criteria
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   Colombia,   France,   Germany,   Hong Kong,   Korea, Republic of,   Mexico,   Philippines,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Bulgaria,   India,   Netherlands,   Peru
 
Administrative Information
NCT Number  ICMJE NCT00428220
Other Study ID Numbers  ICMJE A6181114
2006-006538-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP