Overview
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.
Description
Subjects must 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 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to 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.
Eligibility
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.
Canada Specific:
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.
- Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer 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 they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., 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 is either:
- Of nonchildbearing potential:
- postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) > 40 IU/L at Day 1 for women < 55 years of age),
- documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
- Or, if of childbearing potential,
- must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
- must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
- must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.
The 2 acceptable methods of birth control are as follows or per local guidelines where
these require additional description of contraceptive methods:
- A barrier method (e.g., condom by a male partner) is required; AND
- One of the following is required:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS);
- Additional barrier method including occlusive cap (diaphragm or cervical/vault caps)
with spermicidal foam/gel/film/cream/suppository;
- Vasectomy or other surgical castration at least 6 months before Day 1.
- The subject must not be breastfeeding at Day 1 or during the study period, and for 6
months after the final study drug 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.
Canada Specific:
Subject will be excluded from participation if any of the following apply:
- Subject met any of the discontinuation criteria or whose cancer progressed on the
current enzalutamide clinical study in which they are enrolling from.
- Subject requires treatment with or plans to use any of the following:
- New systemic therapy for their 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 in the opinion of the
investigator.