metastatic castration-resistant prostate cancer MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Astellas Pharma Global Development, Inc.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Subject is eligible for the study if all of the following apply: 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 ? 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. 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 720
Exclusion criteria
Exclusion criteria: Subject will be excluded from participation if any of the following apply: 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 a strong CYP3A4 inducers or strong CYP2C8 inhibitors and using any narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2C9) and CYP2C19 or investigational agents. ? 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 3. Subject is participating in an investigator-initiated interventional trial and receiving enzalutamide. 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 as completed, at a minimum, the primary analysis or the study specified evaluation period. ;Secondary Objective: NA;Primary end point(s): na;Timepoint(s) of evaluation of this end point: na | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Korea, Republic of, Lithuania, Malaysia, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactService Desk - Global Clinical Dev
Astellas Pharma Europe B.V.
Outcome results
None listed