臨床研究等提出・公開システム

A Phase 2 Open-label Extension 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

Derkach Sergii

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo

clinicaltrialregistration@astellas.com

Medical Information Center

Astellas Pharma Inc.

2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo

+81-120-189-371

clinicaltrialregistration@astellas.com

Not Recruiting

May. 17, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. 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 / Pfizer and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible.
2. Subject is able to continue on the treatment regimen that the subject was 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.
3. Subject is able to swallow enzalutamide capsules and comply with study requirements.
4. 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.
5. Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.
6. Subject agrees not to participate in another interventional study while on treatment.

1. Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from.
2. Subject requires treatment with or plans to use either of the following:
o 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.
o Investigational therapy other than enzalutamide.
3. Subject is currently 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.

Male

Prostate cancer

Enzalutamide: Subjects will receive enzalutamide orally once daily at the same time each day.
Enzalutamide plus abiraterone acetate and prednisone: Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) may receive orally abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily.
Enzalutamide plus leuprolide acetate: Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily.
Due to transition from study 9785-CL-0335 in Japan, concomitant use of leuprolide acetate, or abiraterone acetate and prednisone will not be conducted.

Adverse events (AEs)

April. 06, 2023

Yes

Access to anonymized individual participant level data collected during the study, in addition to supporting clinical documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/. Study-related supporting documentation is redacted and provided if available, such as the protocol and amendments, statistical analysis plan and clinical study report. Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data. Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

United States/Argentina/Australia/Belgium/Canada/Chile/Czechia/Denmark/Finland/France/Georgia/Germany/Israel/Italy/Moldova/New Zealand/Poland/Russia/Slovakia/South Africa/South Korea/Spain/Sweden/Taiwan/Thailand/United Kingdom/Hong Kong/China/Austria/Brazil