NCT02960022 : A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase II trial is collecting long term data about patients with prostate cancer, who previously participated in an enzalutamide clinical trial.
 

This trial is treating patients with prostate cancer.

This is a systemic therapy trial extension study.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You are currently receiving treatment for your cancer.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Commercial Sponsor

Astellas Pharma Inc.

Summary

Subjects should continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study). The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 12 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications, confirm that no discontinuation criteria are met, return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit.

Recruiting Hospitals Read MoreRead more

Cabrini Education and Research Precinct
Malvern
Li Hoon Lai
lihoonlai@cabrini.com.au
(03) 9508 3421

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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