Clinical Trials /

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

NCT02960022

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 9785-CL-0123
  • SECONDARY ID: 2016-001694-32
  • NCT ID: NCT02960022

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
enzalutamideMDV3100, Xtandienzalutamide plus abiraterone acetate and prednisone
abiraterone acetateenzalutamide plus abiraterone acetate and prednisone
prednisoneenzalutamide plus abiraterone acetate and prednisone

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
enzalutamideExperimentalSubjects will receive enzalutamide orally once daily at the same time each day
  • enzalutamide
enzalutamide plus abiraterone acetate and prednisoneExperimentalSubjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily
  • enzalutamide
  • abiraterone acetate
  • prednisone

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:Until End of Study (Up to 44 Months)
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Astellas Pharma Global Development, Inc.

Trial Keywords

  • prostate cancer
  • prednisone
  • MDV3100
  • enzalutamide
  • Xtandi
  • abiraterone acetate

Last Updated

October 12, 2017