Study for Prostate Cancer Patients Who Previously Participated in an Enzalutamide Clinical Trial

Sponsor: Astellas Pharma Global Development, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT02960022

Provider View

This study aims to gather long-term safety information from patients who have been benefiting from enzalutamide treatment in a previous clinical trial. Participants will continue their treatment and be monitored for safety and effectiveness.

Patient Parameters

Program Overview

The purpose of this study is to collect long-term safety data from patients who are continuing to benefit from enzalutamide treatment. These patients previously participated in an enzalutamide clinical trial sponsored by Astellas or Medivation, which has completed its main analysis or evaluation period. Participants will continue their treatment regimen from the prior study and will be monitored for safety and effectiveness.

Description

Participants in this study will continue the treatment they were receiving in their previous enzalutamide study. If any changes to the treatment are needed, such as dose adjustments, approval from a medical monitor is required. The first visit for this study should be within 7 days of the last visit from the previous study. Participants will follow their local institution's standard care and return every 24 weeks to review any side effects, update medications, and ensure they still meet the study criteria. Every 12 weeks, participants will return any unused study medication and receive more if needed. All side effects, including serious ones, will be recorded from the time the consent form is signed until the end of the study.

Eligibility Criteria

Inclusion Criteria

  • Currently receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and benefiting from continued treatment.
  • Able to continue the treatment regimen from the prior study, with any changes approved by a medical monitor.
  • Able to swallow enzalutamide capsules and comply with study requirements.
  • Must use two forms of birth control, one highly effective and one barrier method, during the study and for 3 months after the last dose.
  • Must avoid sperm donation during the study and for 3 months after the last dose.
  • Must not participate in another interventional study while on treatment.

Canada Specific:

  • Must have IRB/IEC approved written informed consent and privacy language as per national regulations.
  • Currently receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and benefiting from continued treatment.
  • Able to continue the treatment regimen from the prior study, with any changes approved by a medical monitor.
  • Able to swallow enzalutamide capsules and comply with study requirements.
  • Women of childbearing potential must have a negative pregnancy test before starting the study and use two acceptable methods of birth control during the study and for 6 months after the last dose.
  • Must not donate ova during the study and for 6 months after the last dose.
  • Must not be breastfeeding during the study and for 6 months after the last dose.
  • Must not participate in another interventional study while on treatment.

Exclusion Criteria

  • Met any discontinuation criteria or cancer progressed on the current enzalutamide study.
  • Requires new systemic therapy for cancer (palliative radiation therapy is allowed).
  • Plans to use investigational therapy other than enzalutamide.
  • Currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
  • Has any disease, infection, or condition that interferes with study participation or complicates data interpretation.

Canada Specific:

  • Met any discontinuation criteria or cancer progressed on the current enzalutamide study.
  • Requires new systemic therapy for cancer (palliative radiation therapy is allowed).
  • Plans to use investigational therapy other than enzalutamide.
  • Currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
  • Has any disease, infection, or condition that interferes with study participation or complicates data interpretation.

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