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

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NCT02669771

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Study Location
Aichi, , , Japan
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

By email

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[email protected]

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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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  42. Farmington Hills, Michigan
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  46. Saint Louis, Missouri
  47. Saint Peters, Missouri
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  49. Las Vegas, Nevada
  50. Las Vegas, Nevada
  51. Albuquerque, New Mexico
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  55. New York, New York
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  61. Philadelphia, Pennsylvania
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  64. Pittsburgh, Pennsylvania
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  68. Myrtle Beach, South Carolina
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  72. Gallatin, Tennessee
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  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
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  87. Hampton, Virginia
  88. Mechanicsville, Virginia
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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 December 2020