A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/16/2019
Start Date:December 22, 2016
End Date:July 2021
Contact:Astellas Pharma Global Development
Email:astellas.registration@astellas.com
Phone:800-888-7704

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

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.

Subjects should 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 12
weeks (± 7 days) to review adverse events (AEs), collect concomitant medications, confirm
that no discontinuation criteria are met, 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.

Inclusion Criteria:

- Subject must currently be receiving enzalutamide 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 the subject was receiving 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.

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.
We found this trial at
36
sites
Nashville, Tennessee 37232
618
mi
from
Nashville, TN
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Anchorage, Alaska 99503
2735
mi
from
Anchorage, AK
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Aurora, Colorado 80045
401
mi
from
Aurora, CO
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Chapel Hill, North Carolina 27514
843
mi
from
Chapel Hill, NC
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Charleston, South Carolina 29424
1063
mi
from
Charleston, SC
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Chicago, Illinois 60612
609
mi
from
Chicago, IL
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Cincinnati, Ohio 45242
728
mi
from
Cincinnati, OH
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Concord, North Carolina 28025
968
mi
from
Concord, NC
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Cordorba,
?
mi
from
Cordorba,
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Dallas, Texas 75246
347
mi
from
Dallas, TX
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Daytona Beach, Florida 32114
1131
mi
from
Daytona Beach, FL
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Denver, Colorado 80239
409
mi
from
Denver, CO
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Garden City, New York 11530
1306
mi
from
Garden City, NY
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Greensboro, North Carolina 27403
1001
mi
from
Greensboro, NC
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Hackensack, New Jersey 07601
1285
mi
from
Hackensack, NJ
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Houston, Texas 77030
572
mi
from
Houston, TX
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Jacksonville, Florida 32256
1065
mi
from
Jacksonville, FL
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Jeffersonville, Indiana 47130
658
mi
from
Jeffersonville, IN
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Lancaster, Pennsylvania 17604
1164
mi
from
Lancaster, PA
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Los Angeles, California 90033
1168
mi
from
Los Angeles, CA
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Madison, Wisconsin 53792
575
mi
from
Madison, WI
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Myrtle Beach, South Carolina 29572
1098
mi
from
Myrtle Beach, SC
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Norfolk, Virginia 23502
1186
mi
from
Norfolk, VA
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Omaha, Nebraska 68114
261
mi
from
Omaha, NE
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Pittsburgh, Pennsylvania 15213
971
mi
from
Pittsburgh, PA
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Saint Louis, Missouri 63110
418
mi
from
Saint Louis, MO
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San Bernardino, California 92404
1115
mi
from
San Bernardino, CA
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San Diego, California 92123
1099
mi
from
San Diego, CA
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Seattle, Washington 98101
1410
mi
from
Seattle, WA
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Springfield, Oregon 97477
1379
mi
from
Springfield, OR
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Stanford, California 94305
1329
mi
from
Stanford, CA
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Towson, Maryland 21204
1149
mi
from
Towson, MD
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Tucson, Arizona 85719
833
mi
from
Tucson, AZ
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Virginia Beach, Virginia 23462
1199
mi
from
Virginia Beach, VA
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Washington, District of Columbia 20007
1124
mi
from
Washington,
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Winston-Salem, North Carolina 27157
974
mi
from
Winston-Salem, NC
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