A Phase II Open-Label Extension Study for Subjects with Prostate Cancer who Previously Participated in an Enzalutamide Clinical Study
Considering participating in a START clinical trial?
Study Summary
To evaluate the effect of enzalutamide in subjects with prostate cancer.
To collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide.
To provide access to continued treatment for subjects who are currently participating in an enzalutamide clinical study for their prostate cancer and who are continuing to derive clinical benefit based on the assessment of the investigator
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.
- 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.
- 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.
- 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.
- Subject is able to swallow enzalutamide capsules and comply with study requirements.
- 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
- Barrier methods of contraception: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- Tubal ligation
- Vasectomy or other surgical castration prior to initial screening.
- 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.
- Waivers to the inclusion criteria will NOT be allowed
- Subject met any of the discontinuation criteria or progressed on the current enzalutamide clinical study in which they are 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 in the opinion of the investigator.
- Waivers to the exclusion criteria will NOT be allowed.
Clinical Study Information for Healthcare Providers
By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.