Long-Term Specified Drug Use-Results Survey for Xtandi Capsule

NCT02669771

Last updated date
Study Location
Aichi, , , Japan
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Castration-resistant Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- no history of treatment with enzalutamide

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


-

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  4. Chiba,
  5. Ehime,
  6. Fukui,
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  11. Hiroshima,
  12. Hokkaido,
  13. Hyogo,
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  15. Ishikawa,
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  25. Miyazaki,
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  28. Nara,
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  18. San Diego, California
  19. San Francisco, California
  20. South Pasadena, California
  21. Stanford, California
  22. Stanford, California
  23. Aurora, Colorado
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  27. Washington, District of Columbia
  28. Atlantis, Florida
  29. Palm Beach Gardens, Florida
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  41. Detroit, Michigan
  42. Farmington Hills, Michigan
  43. Rochester, Minnesota
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  47. Saint Peters, Missouri
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  51. Albuquerque, New Mexico
  52. Buffalo, New York
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  56. Durham, North Carolina
  57. Durham, North Carolina
  58. Portland, Oregon
  59. McKeesport, Pennsylvania
  60. Philadelphia, Pennsylvania
  61. Philadelphia, Pennsylvania
  62. Pittsburgh, Pennsylvania
  63. Pittsburgh, Pennsylvania
  64. Pittsburgh, Pennsylvania
  65. Charleston, South Carolina
  66. Charleston, South Carolina
  67. Myrtle Beach, South Carolina
  68. Myrtle Beach, South Carolina
  69. Chattanooga, Tennessee
  70. Dickson, Tennessee
  71. Franklin, Tennessee
  72. Gallatin, Tennessee
  73. Hermitage, Tennessee
  74. Lebanon, Tennessee
  75. Murfreesboro, Tennessee
  76. Nashville, Tennessee
  77. Nashville, Tennessee
  78. Nashville, Tennessee
  79. Nashville, Tennessee
  80. Nashville, Tennessee
  81. Nashville, Tennessee
  82. Smyrna, Tennessee
  83. Dallas, Texas
  84. Dallas, Texas
  85. Dallas, Texas
  86. Chesapeake, Virginia
  87. Hampton, Virginia
  88. Mechanicsville, Virginia
  89. Midlothian, Virginia
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  104. Cipolletti, Provincia DE RIO Negro
  105. Rosario, Provincia DE Santa FE
  106. Rosario, Provincia DE Santa FE
  107. Rosario, Provincia DE Santa FE
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  111. Concord, New South Wales
  112. Port Macquarie, New South Wales
  113. Port Macquarie, New South Wales
  114. Port Macquarie, New South Wales
  115. Randwick, New South Wales
  116. Tweed Heads, New South Wales
  117. Wentworthville, New South Wales
  118. Westmead, New South Wales
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Advanced Information
Descriptive Information
Brief Title Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
Official Title Xtandi® Capsules 40 mg Protocol for Long-Term Specified Drug Use-Results Survey
Brief Summary The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in patients.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with castration-resistant prostate cancer
Condition Castration-resistant Prostate Cancer
Intervention Drug: enzalutamide
oral
Other Names:
  • Xtandi
  • MDV3100
Study Groups/Cohorts Enzalutamide group
oral
Intervention: Drug: enzalutamide
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 Completed
Actual Enrollment
 (submitted: January 17, 2017)
1018
Original Estimated Enrollment
 (submitted: January 28, 2016)
900
Actual Study Completion Date November 30, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • no history of treatment with enzalutamide

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study:Male
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02669771
Other Study ID Numbers 9785-MA-1018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Responsible Party Astellas Pharma Inc
Study Sponsor Astellas Pharma Inc
Collaborators Pfizer
Investigators
Study Director:Medical DirectorAstellas Pharma Inc
PRS Account Astellas Pharma Inc
Verification Date January 2019