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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02960022
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : November 1, 2019
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: enzalutamide Drug: abiraterone acetate Drug: prednisone Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Actual Study Start Date : December 22, 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day
Drug: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
  • MDV3100
  • Xtandi

Experimental: enzalutamide plus abiraterone acetate and prednisone
Subjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide once daily
Drug: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
  • MDV3100
  • Xtandi

Drug: abiraterone acetate
Subjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

Drug: prednisone
Subjects enrolling from study 9785-CL-0011 will receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Until End of Study (Up to 44 Months) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02960022

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Contact: Astellas Pharma Global Development 800-888-7704

Hide Hide 122 study locations
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United States, Alaska
Site US10052 Recruiting
Anchorage, Alaska, United States, 99503
United States, Arizona
Site US10011 Recruiting
Tucson, Arizona, United States, 85741
United States, California
Site US10040 Recruiting
Los Angeles, California, United States, 90024
Site US10009 Completed
Los Angeles, California, United States, 90048
Site US10008 Completed
San Bernardino, California, United States, 92404
Site US10042 Recruiting
San Diego, California, United States, 92108
Site US10028 Completed
Stanford, California, United States, 94305
United States, Colorado
Site US10001 Recruiting
Aurora, Colorado, United States, 80045
Site US10017 Recruiting
Denver, Colorado, United States, 80211
United States, District of Columbia
Site US10050 Completed
Washington, District of Columbia, United States, 20037
United States, Florida
Site US10049 Recruiting
Daytona Beach, Florida, United States, 32114
Site US10048 Withdrawn
Jacksonville, Florida, United States, 32216
United States, Illinois
Site US10002 Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Site US10007 Recruiting
Jeffersonville, Indiana, United States, 47130
United States, Maryland
Site US10029 Recruiting
Towson, Maryland, United States, 21204
United States, Missouri
Site US10032 Recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Site US10023 Recruiting
Omaha, Nebraska, United States, 68130
United States, New Jersey
Site US10004 Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Site US10024 Recruiting
Garden City, New York, United States, 11530
Site US10055 Recruiting
New York, New York, United States, 10065
Site US10059 Recruiting
New York, New York, United States, 10065
Site US10053 Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
Site US10030 Completed
Chapel Hill, North Carolina, United States, 27599
Site US10062 Recruiting
Charlotte, North Carolina, United States, 28207
Site US10020 Withdrawn
Concord, North Carolina, United States, 28025
Site US10031 Recruiting
Greensboro, North Carolina, United States, 27403
Site US10046 Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Site US10035 Completed
Cincinnati, Ohio, United States, 45212
United States, Oregon
Site US10022 Recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Site US10027 Recruiting
Lancaster, Pennsylvania, United States, 17604
Site US10005 Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Site US10018 Recruiting
Charleston, South Carolina, United States, 29414
Site US10003 Withdrawn
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Site US10041 Completed
Nashville, Tennessee, United States, 37232-2765
United States, Texas
Site US10010 Recruiting
Dallas, Texas, United States, 75231
Site US10034 Completed
Houston, Texas, United States, 77024
Site US10043 Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Site US10014 Completed
Norfolk, Virginia, United States, 23502
Site US10015 Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
Site US10038 Recruiting
Seattle, Washington, United States, 98109
United States, Wisconsin
Site US10021 Recruiting
Madison, Wisconsin, United States, 53792
Site AR54003 Recruiting
Cordorba, Argentina
Site AR54002 Recruiting
Tucuman, Argentina
Australia, New South Wales
Site AU61001 Completed
Tweed Heads, New South Wales, Australia, 2485
Site AU61006 Recruiting
Ashford, Australia
Site AU61009 Recruiting
Malvern, Australia
Site AU61008 Completed
South Brisbane, Australia
Site AU61004 Completed
Westmead, Australia
Site BE32002 Recruiting
Kortrijk, West-Vlaanderen, Belgium, 8500
Site BE32004 Recruiting
Brussels, Belgium, B-1090
Site BE32005 Withdrawn
Gent, Belgium, 9000
Site BE32007 Completed
Hasselt, Belgium
Site BE32008 Recruiting
Leuven, Belgium, 3000
Site BE32001 Recruiting
Liege, Belgium, 4000
Site BE32003 Recruiting
Turnhout, Belgium, 2300
Canada, Ontario
Site CA15003 Recruiting
Kingston, Ontario, Canada, K7L 3J7
Canada, Quebec
Site CA15001 Recruiting
Granby, Quebec, Canada, J2G 8Z9
Site CA15011 Recruiting
Montreal, Canada
Site CL56004 Recruiting
IX Region, Chile
Site CL56002 Recruiting
Santiago, Chile
Site CL56001 Recruiting
Vina del Mar, Chile
Site CZ42002 Recruiting
Olomouc, Czechia, 779 00
Site CZ42003 Recruiting
Praha 2, Czechia
Site CZ42001 Recruiting
Praha 6, Czechia, 16000
Site DK45002 Recruiting
Aalborg, Nordjylland, Denmark, 9000
Site DK45003 Recruiting
Aarhus, Denmark, 8200
Site DK45001 Recruiting
Copenhagen, Denmark, 2100
Site DK45004 Recruiting
Herlev, Denmark, 2730
Site FL35802 Recruiting
Tampere, Finland
Site FR33008 Completed
La Roche sur Yon, France, 85925
Site FR33010 Completed
Lille, France, 59037
Site FR33002 Recruiting
Lyon Cedex 3, France, 69003
Site FR33006 Completed
Nimes, France, 30029
Site FR33003 Completed
Paris, France
Site FR33017 Recruiting
Paris, France
Site FR33001 Completed
Saint Herblain, France
Site FR33004 Recruiting
Villejuif, France
Site GE99501 Completed
Tbilisi, Georgia, GE- 0186
Site DE49004 Recruiting
Nürtingen, Baden-Württemberg, Germany, 72622
Site DE49007 Completed
Waldshut-Tiengen, Baden-Württemberg, Germany, 79761
Site DE49006 Recruiting
Mannheim, DE, Germany, 68167
Site DE49001 Recruiting
Duisburg, NRW, Germany, 47179
Site DE49010 Recruiting
Bonn, Germany, 53111
Site DE49003 Recruiting
Hamburg, Germany, 22081
Site DE49013 Recruiting
Hamburg, Germany
Site IL97202 Recruiting
Peth Tikva, Israel
Site IL97204 Recruiting
Ramat-Gan, Israel
Site IL97203 Completed
Tzrifin Beer Yakov, Israel
Site IT39001 Recruiting
Arezzo, Italy
Site IT39004 Recruiting
Cremona, Italy
Site IT39002 Recruiting
Forli, Italy
Site IT39005 Recruiting
Roma, Italy
Korea, Republic of
Site KR82005 Recruiting
Seongnam-si, Korea, Republic of
Site KR82001 Recruiting
Seoul, Korea, Republic of
Site KR82002 Recruiting
Seoul, Korea, Republic of
Site KR82003 Recruiting
Seoul, Korea, Republic of
Site KR82004 Recruiting
Seoul, Korea, Republic of
Moldova, Republic of
Site MD37301 Recruiting
Chisinau, Moldova, Republic of
New Zealand
Site NZ64001 Recruiting
Hamilton, New Zealand
Site PL48002 Recruiting
Gdansk, Poland
Site PL48001 Recruiting
Myslowice, Poland
Site PL48004 Recruiting
Pozman, Poland
Site PL48003 Completed
Wroclaw, Poland
Russian Federation
Site RU70001 Completed
Moscow, Russian Federation
Site RU70003 Recruiting
St. Petersburg, Russian Federation
Site SK10223 Recruiting
Bratislava, Slovakia
South Africa
Site ZA27001 Recruiting
George, South Africa, 6529
Site ES34003 Recruiting
Barcelona, Spain
Site ES34004 Withdrawn
Barcelona, Spain
Site ES34001 Completed
Madrid, Spain, 28034
Site ES34005 Recruiting
Pamplona, Spain
Site SE46001 Recruiting
Göteborg, Sweden, 41345
Site SE46003 Recruiting
Umeå, Sweden, 90185
United Kingdom
Site GB44009 Recruiting
Bebington, United Kingdom
Site GB44003 Recruiting
Belfast, United Kingdom
Site GB44004 Recruiting
Bristol, United Kingdom, BS28HW
Site GB44005 Recruiting
Cardiff, United Kingdom, CF4 4XN
Site GB44002 Completed
Glasgow, United Kingdom
Site GB44006 Recruiting
London, United Kingdom
Site GB44007 Recruiting
Manchester, United Kingdom, M20 4BX
Site GB44008 Recruiting
Northwood, United Kingdom
Site GB44001 Recruiting
Sutton, United Kingdom
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
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Study Director: Associate Medical Director Astellas Pharma Global Development, Inc.

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Responsible Party: Astellas Pharma Global Development, Inc. Identifier: NCT02960022    
Other Study ID Numbers: 9785-CL-0123
2016-001694-32 ( EudraCT Number )
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
prostate cancer
abiraterone acetate
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Abiraterone Acetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Cytochrome P-450 Enzyme Inhibitors