Long-Term Specified Drug Use-Results Survey for Xtandi Capsule
NCT02669771
Last updated date
ABOUT THIS STUDY
The purpose of this study is to confirm the long term safety and efficacy of enzalutamide in
patients.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Castration-resistant Prostate Cancer
Sex
Male
Age
0 +
Inclusion Criteria
Show details
- no history of treatment with enzalutamide
Exclusion Criteria
Show details
-
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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:
| ||||
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 | 1018 | ||||
Original Estimated Enrollment | 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:
Exclusion Criteria: - | ||||
Sex/Gender |
| ||||
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 |
| ||||
Responsible Party | Astellas Pharma Inc | ||||
Study Sponsor | Astellas Pharma Inc | ||||
Collaborators | Pfizer | ||||
Investigators |
| ||||
PRS Account | Astellas Pharma Inc | ||||
Verification Date | December 2020 |