A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

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NCT00375674

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Study Location
Ronald Reagan UCLA Medical Center Department of Pharmaceutical Services
Los Angeles, California, 90095, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney Neoplasms
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

- High risk renal cancer per modified UISS criteria

- Eastern Cooperative Oncology Group (ECOG) 0-2

- predominant clear cell histology

- No prior anti-cancer treatment

- Kidney tumor has been removed

- No evidence of macroscopic disease following surgery

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


- Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
sarcoma or subjects with metastatic renal sites.


- Diagnosis of any second malignancy within the last 5 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that
has been adequately treated with no evidence of recurrent disease for 12 months


- known HIV or Hepatitis


- any severe acute or chronic medical or psychiatric condition or laboratory abnormality
that may increase the risk associated with study participation or study drug
administration

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Pfizer Clinical Trials Contact Center

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[email protected]

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Kidney NeoplasmsAxitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer NCT00678392
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  2. Burbank, California
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  4. Glendale, California
  5. Los Angeles, California
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  14. Whittier, California
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  18. Boulder, Colorado
  19. Colorado Springs, Colorado
  20. Denver, Colorado
  21. Denver, Colorado
  22. Lakewood, Colorado
  23. Littleton, Colorado
  24. Lone Tree, Colorado
  25. Longmont, Colorado
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  27. Thornton, Colorado
  28. Washington, District of Columbia
  29. Washington, District of Columbia
  30. Bonita Springs, Florida
  31. Bradenton, Florida
  32. Cape Coral, Florida
  33. Cape Coral, Florida
  34. Deerfield Beach, Florida
  35. Englewood, Florida
  36. Fort Myers, Florida
  37. Fort Myers, Florida
  38. Fort Myers, Florida
  39. Fort Myers, Florida
  40. Miami, Florida
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  42. Naples, Florida
  43. Orlando, Florida
  44. Orlando, Florida
  45. Port Charlotte, Florida
  46. Sarasota, Florida
  47. Sarasota, Florida
  48. Venice, Florida
  49. Venice, Florida
  50. Atlanta, Georgia
  51. Ringgold, Georgia
  52. Boise, Idaho
  53. Fruitland, Idaho
  54. Meridian, Idaho
  55. Nampa, Idaho
  56. Twin Falls, Idaho
  57. Maywood, Illinois
  58. Carmel, Indiana
  59. Fishers, Indiana
  60. Greenfield, Indiana
  61. Indianapolis, Indiana
  62. Indianapolis, Indiana
  63. Boston, Massachusetts
  64. Boston, Massachusetts
  65. Ann Arbor, Michigan
  66. Detroit, Michigan
  67. Farmington Hills, Michigan
  68. Minneapolis, Minnesota
  69. Columbia, Missouri
  70. Saint Louis, Missouri
  71. Saint Louis, Missouri
  72. Washington, Missouri
  73. Henderson, Nevada
  74. Las Vegas, Nevada
  75. Las Vegas, Nevada
  76. Las Vegas, Nevada
  77. Las Vegas, Nevada
  78. Hackensack, New Jersey
  79. Hackensack, New Jersey
  80. Hackensack, New Jersey
  81. Bronx, New York
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  85. Oswego, New York
  86. Syracuse, New York
  87. Syracuse, New York
  88. Cary, North Carolina
  89. Durham, North Carolina
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  105. Hershey, Pennsylvania
  106. Philadelphia, Pennsylvania
  107. Charleston, South Carolina
  108. Easley, South Carolina
  109. Greenville, South Carolina
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  115. Franklin, Tennessee
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  160. Seattle, Washington
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  163. Kurralta Park, South Australia
  164. Ballarat, Victoria
  165. East Melbourne, Victoria
  166. Heidelberg West, Victoria
  167. Heidelberg, Victoria
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  172. Barretos, SP
  173. Sao Paulo, SP
  174. Calgary, Alberta
  175. Edmonton, Alberta
  176. Kelowna, British Columbia
  177. Moncton, New Brunswick
  178. St. John's, Newfoundland and Labrador
  179. Oshawa, Ontario
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  185. Shanghai,
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  188. Bordeaux Cedex,
  189. CRETEIL Cedex,
  190. Marseille Cedex 09,
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  192. Rennes,
  193. St Herblain Cedex,
  194. Tours Cedex 1,
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  196. Villejuif Cedex,
  197. Aachen,
  198. Berlin,
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Kidney NeoplasmsStudy of the Safety and Efficacy of SU-011,248 in Adult Patients With Advanced Kidney Cancer NCT00054886
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  2. Mission Hills, California
  3. Monterey Park, California
  4. Northridge, California
  5. San Francisco, California
  6. San Francisco, California
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Ann Arbor, Michigan
  10. Henderson, Nevada
  11. Las Vegas, Nevada
  12. Las Vegas, Nevada
  13. New York, New York
  14. Philadelphia, Pennsylvania
  15. Madison, Wisconsin
ALL GENDERS
18 Years+
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Kidney NeoplasmsAxitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer NCT00920816
  1. Miami, Florida
  2. Miami, Florida
  3. Arlington Heights, Illinois
  4. Niles, Illinois
  5. Carmel, Indiana
  6. Fishers, Indiana
  7. Greenfield, Indiana
  8. Indianapolis, Indiana
  9. Indianapolis, Indiana
  10. Columbia, Missouri
  11. Omaha, Nebraska
  12. Henderson, Nevada
  13. Henderson, Nevada
  14. Henderson, Nevada
  15. Las Vegas, Nevada
  16. Las Vegas, Nevada
  17. Las Vegas, Nevada
  18. Morristown, New Jersey
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  20. Albany, New York
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  24. Troy, New York
  25. Cary, North Carolina
  26. Raleigh, North Carolina
  27. Raleigh, North Carolina
  28. Portland, Oregon
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  30. Portland, Oregon
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  39. Fort Worth, Texas
  40. Fort Worth, Texas
  41. Fort Worth, Texas
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  43. Fort Worth, Texas
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  50. Webster, Texas
  51. Weslaco, Texas
  52. Christiansburg, Virginia
  53. Low Moor, Virginia
  54. Roanoke, Virginia
  55. Salem, Virginia
  56. Wytheville, Virginia
  57. Vancouver, Washington
  58. Vancouver, Washington
  59. Wenatchee, Washington
  60. Banja Luka,
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  62. Tuzla,
  63. Sofia,
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  65. Temuco, Cautin
  66. Temuco, IX Region
  67. Providencia, Santiago
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  71. Fuzhou, Fujian
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  76. Changchun, Jilin
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  86. Shanghai,
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  90. Bangalore, Karnataka
  91. Bangalore, Karnataka
  92. Bangalore, Karnataka
  93. Nagpur, Maharashtra
  94. Nashik, Maharashtra
  95. Nashik, Maharashtra
  96. Pune, Maharashtra
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  101. Toluca, Estado DE Mexico
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  106. Quezon City, Metro Manila
  107. Makati City,
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  109. Timisoara, JUD. Timis
  110. Cluj-Napoca,
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  112. Moscow,
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  114. Ryazan,
  115. Ryazan,
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  119. Taichung,
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  121. Dnipropetrovsk,
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer
Official Title  ICMJE Sunitinib Treatment Of Renal Adjuvant Cancer (S-trac): A Randomized Double-blind Phase 3 Study Of Adjuvant Sunitinib Vs. Placebo In Subjects At High Risk Of Recurrent Rcc
Brief Summary To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Kidney Neoplasms
Intervention  ICMJE
  • Drug: Sunitinib malate
    sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
  • Other: Placebo
    Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Sunitinib malate
  • Placebo Comparator: B
    Intervention: Other: Placebo
Publications *

*   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: July 19, 2017)		674
Original Enrollment  ICMJE
 (submitted: September 12, 2006)		228
Actual Study Completion Date  ICMJE September 7, 2017
Actual Primary Completion Date April 7, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • High risk renal cancer per modified UISS criteria
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • predominant clear cell histology
  • No prior anti-cancer treatment
  • Kidney tumor has been removed
  • No evidence of macroscopic disease following surgery

Exclusion Criteria:

  • Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
  • Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
  • known HIV or Hepatitis
  • any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
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 Australia,   China,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Slovakia,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Austria,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00375674
Other Study ID Numbers  ICMJE A6181109
2006-004024-37 ( EudraCT Number )
S-TRAC ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
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 August 2018

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