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.
Recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| enzalutamide | MDV3100, Xtandi | enzalutamide |
| abiraterone acetate | enzalutamide plus abiraterone acetate and prednisone | |
| prednisone | enzalutamide plus abiraterone acetate and prednisone |
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| enzalutamide | Experimental | Subjects will receive enzalutamide orally once daily at the same time each day |
|
| enzalutamide plus abiraterone acetate and prednisone | Experimental | Subjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily |
|
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 |
| Measure: | Number of participants with adverse events |
| Time Frame: | Until End of Study (Up to 96 Months) |
| Safety Issue: | |
| Description: |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Astellas Pharma Global Development, Inc. |
August 27, 2021
