prostate cancer metastatic prostate cancer
Conditions
Interventions
Subjects will receive 160 mg (4 capsules) of enzalutamide orally once daily at
the same time each day.
Subjects who experience a grade 3 or higher toxicity that is attributed to the
study drug and
Sponsors
Astellas Pharma Global Development, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. IRB/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. 2. Subject must currently be receiving enzalutamide for prostate 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. 3. Subjects are 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 approval (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. 4. Subject is able to swallow enzalutamide capsules and comply with study requirements. 5. Subject and his 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. Two acceptable forms of birth control include: * Condom (barrier method of contraception), AND * In addition to a condom, 1 of the following acceptable forms of contraception is required: * Established use of oral, injected or implanted hormonal methods of contraception * Placement of an intrauterine device or intrauterine system * Tubal ligation * Vasectomy or other surgical castration prior to initial screening. 6. Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration. 7. Subject agrees not to participate in another interventional study while on treatment. Waivers to the inclusion criteria will NOT be allowed
Exclusion criteria
Exclusion criteria: 1. Subject met any of the discontinuation criteria or progressed on the current enzalutamide clinical study in which they are enrolling from. 2. Subject requires treatment with or plans to use either 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 (e.g., ADT). * Investigational therapy other than enzalutamide 3. Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of the study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide (as assessed by the investigator) from their participation in an enzalutamide clinical study sponsored by Astellas or Medivation, Inc., a wholly owned subsidiary of Pfizer Inc. (Medivation/Pfizer) which has completed, at a minimum, the primary analysis or the study specified evaluation period. Subjects should continue on the treatment regimen that they were receiving in the study they are enrolling from until any of the discontinuation criteria are met as outlined below. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval: monotherapy with enzalutamide or any dose change of the combination compound and background therapy. If enzalutamide is discontinued from a combination therapy, subject is to be taken off the study. | — |
Countries
Netherlands
Outcome results
None listed