A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
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
Study locations (50)
Site US10052
Anchorage, Alaska, 99503
Site US10011
Tucson, Arizona, 85741
Site US10040
Los Angeles, California, 90024
Site US10009
Los Angeles, California, 90048
Site US10067
Orange, California, 92868
Site US10008
San Bernardino, California, 92404
Site US10042
San Diego, California, 92108
Site US10028
Stanford, California, 94305
Site US10001
Aurora, Colorado, 80045
Site US10017
Denver, Colorado, 80211
Site US10050
Washington D.C., District of Columbia, 20037
Site US10049
Daytona Beach, Florida, 32114
Site US10048
Jacksonville, Florida, 32216
Site US10002
Chicago, Illinois, 60637
Springfield Clinic, LLP
Springfield, Illinois, 62701
Site US10007
Jeffersonville, Indiana, 47130
University of Kansas Medical Center
Kansas City, Kansas, 66160
Site US10066
Lenexa, Kansas, 66214-1656
Site US10029
Towson, Maryland, 21204
Site US10032
St Louis, Missouri, 63110
Nebraska Medical Hospital
Omaha, Nebraska, 68114
Site US10023
Omaha, Nebraska, 68130
Site US10004
Hackensack, New Jersey, 07601
Site US10024
Garden City, New York, 11530
Site US10055
New York, New York, 10065
Site US10059
New York, New York, 10065
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601
Site US10053
Syracuse, New York, 13210
Site US10030
Chapel Hill, North Carolina, 27599
Site US10062
Charlotte, North Carolina, 28207
Site US10020
Concord, North Carolina, 28025
Site US10031
Greensboro, North Carolina, 27403
Eastern Urological Associates
Greenville, North Carolina, 27834
Site US10046
Winston-Salem, North Carolina, 27157
Site US10035
Cincinnati, Ohio, 45212
Site US10022
Springfield, Oregon, 97477
Site US10027
Lancaster, Pennsylvania, 17604
Site US10005
Pittsburgh, Pennsylvania, 15232
Site US10018
Charleston, South Carolina, 29414
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Site US10003
Myrtle Beach, South Carolina, 29572
Site US10041
Nashville, Tennessee, 37232-2765
Site US10010
Dallas, Texas, 75231
Site US10034
Houston, Texas, 77024
Site US10043
Houston, Texas, 77030
Site US10014
Norfolk, Virginia, 23502
Site US10015
Virginia Beach, Virginia, 23462
Virginia Mason Medical Center
Seattle, Washington, 98101
Site US10038
Seattle, Washington, 98109
Site US10021
Madison, Wisconsin, 53792