ClinicaliQ Trial Snapshot
- A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study — Recruiting • Phase II • Oncology • NCT02960022.
- What is being tested: Long-term safety monitoring of enzalutamide in prostate cancer patients who are continuing to benefit from treatment in previous Astellas or Medivation-sponsored clinical trials, with focus on extended follow-up data collection.
- Patient eligibility overview: Subjects must have previously participated in an enzalutamide clinical study for prostate cancer and must be demonstrating ongoing clinical benefit from continued enzalutamide treatment at study entry.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) 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 they were receiving or were assigned to receive 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: *…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.