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

Use our guide to learn which trials are right for you!

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
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Anchorage, Alaska 99503
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Chapel Hill, North Carolina 27514
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Charleston, South Carolina 29424
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Chicago, Illinois 60612
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Concord, North Carolina 28025
?
mi
from
Concord, NC
Click here to add this to my saved trials
Cordorba,
?
mi
from
Cordorba,
Click here to add this to my saved trials
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Daytona Beach, Florida 32114
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80239
?
mi
from
Denver, CO
Click here to add this to my saved trials
Garden City, New York 11530
?
mi
from
Garden City, NY
Click here to add this to my saved trials
Greensboro, North Carolina 27403
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Jeffersonville, Indiana 47130
?
mi
from
Jeffersonville, IN
Click here to add this to my saved trials
Lancaster, Pennsylvania 17604
?
mi
from
Lancaster, PA
Click here to add this to my saved trials
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
Myrtle Beach, South Carolina 29572
?
mi
from
Myrtle Beach, SC
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
San Bernardino, California 92404
?
mi
from
San Bernardino, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Seattle, Washington 98101
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Springfield, Oregon 97477
?
mi
from
Springfield, OR
Click here to add this to my saved trials
Stanford, California 94305
?
mi
from
Stanford, CA
Click here to add this to my saved trials
Towson, Maryland 21204
?
mi
from
Towson, MD
Click here to add this to my saved trials
Tucson, Arizona 85719
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Virginia Beach, Virginia 23462
?
mi
from
Virginia Beach, VA
Click here to add this to my saved trials
Washington, District of Columbia 20007
?
mi
from
Washington,
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials