A study for subjects with prostate cancer who previously participated in an enzalutamide clinical study
A study for subjects with prostate cancer who previously participated in an enzalutamide clinical study
ClinicalTrials.gov ID: NCT02960022
Sponsor: Astellas Pharma Global Development, Inc.
Information provided by: Astellas Pharma Inc (Astellas Pharma Global Development, Inc.) (Responsible Party)
Last Update Posted: 2024-12-09
Brief Summary:
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.
Detailed 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.
Official Title:
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Intervention / Treatment:
- Drug: enzalutamide
- Drug: abiraterone acetate
- Drug: prednisone
| Category | Value |
|---|---|
| Study Start (Actual) |
2016-12-22
|
| Primary Completion (Estimated) |
2026-07-31
|
| Study Completion (Estimated) |
2026-07-31
|
| Enrollment (Estimated) | 900 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
9785-CL-0123
2016-001694-32 (EudraCT Number) 2023-510298-33-00 (Registry Identifier) (REGISTRY: EU CTIS) jRCT2031220674 (Registry Identifier) (REGISTRY: jRCT) |