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RecruitingInterventionalPhase 2

A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

NCT ID: NCT02960022Sponsor: Astellas Pharma Global Development, Inc.Last updated: 2026-04-13

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) unless the subject is on treatment suspension. 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. After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.

Arms & interventions

  • Drugenzalutamide

    Subjects will receive enzalutamide orally once daily at the same time each day.

  • Drugabiraterone acetate

    Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

  • Drugprednisone

    Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

  • DrugLeuprolide acetate

    Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Outcome measures

Primary

  • Number of participants with adverse events

    Time frame: Until End of Study (Up to 96 Months)

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * 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: * Institutional Review Board (IRB)/Independent Ethics Committee (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 breast 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. * Subject is 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 (e.g., 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 is either: * Of nonchildbearing potential: * postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age), * documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1), * Or, if of childbearing potential, * must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered, * must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration, * must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration. The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods: * A barrier method (e.g., condom by a male partner) is required; AND * One of the following is required: * Placement of an intrauterine device (IUD) or intrauterine system (IUS); * Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; * Vasectomy or other surgical castration at least 6 months before Day 1. * The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration. * Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is 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. Canada Specific: Subject will be excluded from participation if any of the following apply: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from. * Subject requires treatment with or plans to use any of the following: * 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. * 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.

Study locations (50)

Site US10052

Anchorage, Alaska, 99503

Completed

Site US10011

Tucson, Arizona, 85741

Completed

Site US10040

Los Angeles, California, 90024

Completed

Site US10009

Los Angeles, California, 90048

Completed

Site US10067

Orange, California, 92868

Recruiting

Site US10008

San Bernardino, California, 92404

Completed

Site US10042

San Diego, California, 92108

Completed

Site US10028

Stanford, California, 94305

Completed

Site US10001

Aurora, Colorado, 80045

Completed

Site US10017

Denver, Colorado, 80211

Completed

Site US10050

Washington D.C., District of Columbia, 20037

Completed

Site US10049

Daytona Beach, Florida, 32114

Completed

Site US10048

Jacksonville, Florida, 32216

Withdrawn

Site US10002

Chicago, Illinois, 60637

Active Not Recruiting

Springfield Clinic, LLP

Springfield, Illinois, 62701

Active Not Recruiting

Site US10007

Jeffersonville, Indiana, 47130

Completed

University of Kansas Medical Center

Kansas City, Kansas, 66160

Active Not Recruiting

Site US10066

Lenexa, Kansas, 66214-1656

Active Not Recruiting

Site US10029

Towson, Maryland, 21204

Completed

Site US10032

St Louis, Missouri, 63110

Completed

Nebraska Medical Hospital

Omaha, Nebraska, 68114

Active Not Recruiting

Site US10023

Omaha, Nebraska, 68130

Active Not Recruiting

Site US10004

Hackensack, New Jersey, 07601

Active Not Recruiting

Site US10024

Garden City, New York, 11530

Active Not Recruiting

Site US10055

New York, New York, 10065

Completed

Site US10059

New York, New York, 10065

Completed

Hudson Valley Urology, PC

Poughkeepsie, New York, 12601

Active Not Recruiting

Site US10053

Syracuse, New York, 13210

Completed

Site US10030

Chapel Hill, North Carolina, 27599

Completed

Site US10062

Charlotte, North Carolina, 28207

Active Not Recruiting

Site US10020

Concord, North Carolina, 28025

Withdrawn

Site US10031

Greensboro, North Carolina, 27403

Terminated

Eastern Urological Associates

Greenville, North Carolina, 27834

Completed

Site US10046

Winston-Salem, North Carolina, 27157

Completed

Site US10035

Cincinnati, Ohio, 45212

Completed

Site US10022

Springfield, Oregon, 97477

Completed

Site US10027

Lancaster, Pennsylvania, 17604

Completed

Site US10005

Pittsburgh, Pennsylvania, 15232

Active Not Recruiting

Site US10018

Charleston, South Carolina, 29414

Active Not Recruiting

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Active Not Recruiting

Site US10003

Myrtle Beach, South Carolina, 29572

Withdrawn

Site US10041

Nashville, Tennessee, 37232-2765

Active Not Recruiting

Site US10010

Dallas, Texas, 75231

Active Not Recruiting

Site US10034

Houston, Texas, 77024

Completed

Site US10043

Houston, Texas, 77030

Active Not Recruiting

Site US10014

Norfolk, Virginia, 23502

Completed

Site US10015

Virginia Beach, Virginia, 23462

Active Not Recruiting

Virginia Mason Medical Center

Seattle, Washington, 98101

Active Not Recruiting

Site US10038

Seattle, Washington, 98109

Completed

Site US10021

Madison, Wisconsin, 53792

Active Not Recruiting