A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

  • Interventional
  • Not Recruiting
  • NCT02960022
Eligibility Details Visit Clinicaltrials.gov

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

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

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.

Gender
Male

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Subject must currently be receiving enzalutamide for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.

         - Subject is able to continue on the treatment regimen that the subject was receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment.

         - Subject is able to swallow enzalutamide capsules and comply with study requirements.

         - Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration.

         - Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.

         - Subject agrees not to participate in another interventional study while on treatment.

        Exclusion Criteria:

         - Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.

         - Subject requires treatment with or plans to use either of the following:

             - New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment.

             - Investigational therapy other than enzalutamide.

         - Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.

         - Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data.

At a Glance

National Government IDNCT02960022

IRB#IRB16-0967

Lead SponsorAstellas Pharma Global Development, Inc.

Lead PhysicianRussell Z. Szmulewitz

Collaborator(s)N/A

EligibilityMale
18 Years and up
Not Recruiting