Prostate Cancer Clinical Trial

A 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.

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Full 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). 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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

900

Study ID:

NCT02960022

Recruitment Status:

Recruiting

Sponsor:

Astellas Pharma Global Development, Inc.

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There are 81 Locations for this study

See Locations Near You

Site US10052
Anchorage Alaska, 99503, United States
Site US10011
Tucson Arizona, 85741, United States
Site US10040
Los Angeles California, 90024, United States
Site US10009
Los Angeles California, 90048, United States
Site US10008
San Bernardino California, 92404, United States
Site US10042
San Diego California, 92108, United States
Site US10028
Stanford California, 94305, United States
Site US10001
Aurora Colorado, 80045, United States
Site US10017
Denver Colorado, 80211, United States
Site US10050
Washington District of Columbia, 20037, United States
Site US10049
Daytona Beach Florida, 32114, United States
Site US10048
Jacksonville Florida, 32216, United States
Site US10002
Chicago Illinois, 60637, United States
Site US10007
Jeffersonville Indiana, 47130, United States
Site US10066
Lenexa Kansas, 66214, United States
Site US10029
Towson Maryland, 21204, United States
Site US10032
Saint Louis Missouri, 63110, United States
Site US10023
Omaha Nebraska, 68130, United States
Site US10004
Hackensack New Jersey, 07601, United States
Site US10024
Garden City New York, 11530, United States
Site US10055
New York New York, 10065, United States
Site US10059
New York New York, 10065, United States
Site US10053
Syracuse New York, 13210, United States
Site US10030
Chapel Hill North Carolina, 27599, United States
Site US10062
Charlotte North Carolina, 28207, United States
Site US10020
Concord North Carolina, 28025, United States
Site US10031
Greensboro North Carolina, 27403, United States
Site US10046
Winston-Salem North Carolina, 27157, United States
Site US10035
Cincinnati Ohio, 45212, United States
Site US10022
Springfield Oregon, 97477, United States
Site US10027
Lancaster Pennsylvania, 17604, United States
Site US10005
Pittsburgh Pennsylvania, 15232, United States
Site US10018
Charleston South Carolina, 29414, United States
Site US10003
Myrtle Beach South Carolina, 29572, United States
Site US10041
Nashville Tennessee, 37232, United States
Site US10010
Dallas Texas, 75231, United States
Site US10034
Houston Texas, 77024, United States
Site US10043
Houston Texas, 77030, United States
Site US10014
Norfolk Virginia, 23502, United States
Site US10015
Virginia Beach Virginia, 23462, United States
Site US10038
Seattle Washington, 98109, United States
Site US10021
Madison Wisconsin, 53792, United States
Site AR54005
Buenos Aires Caba, C1120, Argentina
Site AR54003
Cordorba , , Argentina
Site AR54002
Tucuman , , Argentina
Site AU61014
Albury New South Wales, 2640, Australia
Site AU61001
Tweed Heads New South Wales, 2485, Australia
Site AU61006
Ashford , , Australia
Site AU61009
Malvern , , Australia
Site AU61008
South Brisbane , , Australia
Site AU61004
Westmead , 2145, Australia
Site AU61004
Westmead , , Australia
Site BE32002
Kortrijk West-Vlaanderen, 8500, Belgium
Site BE32004
Brussels , B-109, Belgium
Site BE32005
Gent , 9000, Belgium
Site BE32011
Gent , 9000, Belgium
Site BE32007
Hasselt , , Belgium
Site BE32008
Leuven , 3000, Belgium
Site BE32001
Liege , 4000, Belgium
Site BE32003
Turnhout , 2300, Belgium
Site CA15003
Kingston Ontario, K7L 3, Canada
Site CA15001
Granby Quebec, J2G 8, Canada
Site CA15011
Montreal , , Canada
Site CL56004
IX Region , , Chile
Site CL56002
Santiago , , Chile
Site CL56001
Vina del Mar , , Chile
Site CZ42002
Olomouc , 779 0, Czechia
Site CZ42003
Praha 2 , , Czechia
Site CZ42001
Praha 6 , 16000, Czechia
Site DK45002
Aalborg Nordjylland, 9000, Denmark
Site DK45003
Aarhus , 8200, Denmark
Site DK45001
Copenhagen , 2100, Denmark
Site DK45004
Herlev , 2730, Denmark
Site FL35802
Tampere , , Finland
Site FR33008
La Roche sur Yon , 85925, France
Site FR33010
Lille , 59037, France
Site FR33002
Lyon Cedex 3 , 69003, France
Site FR33020
Montpellier Cedex , 34298, France
Site FR33006
Nimes , 30029, France
Site FR33003
Paris , , France
Site FR33017
Paris , , France
Site FR33001
Saint Herblain , , France
Site FR33019
Strasbourg , 67000, France
Site FR33004
Villejuif , , France
Site GE99501
Tbilisi , GE- 0, Georgia
Site DE49004
Nürtingen Baden-Württemberg, 72622, Germany
Site DE49007
Waldshut-Tiengen Baden-Württemberg, 79761, Germany
Site DE49006
Mannheim DE, 68167, Germany
Site DE49001
Duisburg NRW, 47179, Germany
Site DE49010
Bonn , 53111, Germany
Site DE49003
Hamburg , 22081, Germany
Site DE49013
Hamburg , , Germany
Site IL97202
Peth Tikva , , Israel
Site IL97204
Ramat-Gan , , Israel
Site IL97203
Tzrifin Beer Yakov , , Israel
Site IT39001
Arezzo , , Italy
Site IT39004
Cremona , , Italy
Site IT39002
Forli , , Italy
Site IT39005
Roma , , Italy
Site KR82005
Seongnam-si , , Korea, Republic of
Site KR82001
Seoul , , Korea, Republic of
Site KR82002
Seoul , , Korea, Republic of
Site KR82003
Seoul , , Korea, Republic of
Site KR82004
Seoul , , Korea, Republic of
Site MD37301
Chisinau , , Moldova, Republic of
Site NZ64001
Hamilton , , New Zealand
Site PL48002
Gdansk , , Poland
Site PL48001
Myslowice , , Poland
Site PL48004
Pozman , , Poland
Site PL48003
Wroclaw , , Poland
Site RU70001
Moscow , , Russian Federation
Site RU70003
St. Petersburg , , Russian Federation
Site SK10223
Bratislava , , Slovakia
Site SK42105
Nitra , 949 0, Slovakia
Site ZA27001
George , 6529, South Africa
Site ES34003
Barcelona , , Spain
Site ES34004
Barcelona , , Spain
Site ES34001
Madrid , 28034, Spain
Site ES34005
Pamplona , , Spain
Site SE46001
Göteborg , 41345, Sweden
Site SE46003
Umeå , 90185, Sweden
Site TW88603
Kaohsiung , 81362, Taiwan
Site TW88602
Taichung , 40447, Taiwan
Site GB44009
Bebington , , United Kingdom
Site GB44003
Belfast , , United Kingdom
Site GB44004
Bristol , BS28H, United Kingdom
Site GB44005
Cardiff , CF4 4, United Kingdom
Site GB44002
Glasgow , , United Kingdom
Site GB44006
London , , United Kingdom
Site GB44007
Manchester , M20 4, United Kingdom
Site GB44008
Northwood , , United Kingdom
Site GB44001
Sutton , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

900

Study ID:

NCT02960022

Recruitment Status:

Recruiting

Sponsor:


Astellas Pharma Global Development, Inc.

How clear is this clinincal trial information?

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