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

Sponsor
Astellas Pharma Global Development, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02960022
Collaborator
Pfizer (Industry)
900
Enrollment
127
Locations
2
Arms
95.3
Anticipated Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

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). 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 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 :
Dec 22, 2016
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

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 or MDV3100-10 (PLATO) study may 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 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

    Drug: prednisone
    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

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events [Until End of Study (Up to 96 Months)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site US10052 Anchorage Alaska United States 99503
    2 Site US10011 Tucson Arizona United States 85741
    3 Site US10040 Los Angeles California United States 90024
    4 Site US10009 Los Angeles California United States 90048
    5 Site US10008 San Bernardino California United States 92404
    6 Site US10042 San Diego California United States 92108
    7 Site US10028 Stanford California United States 94305
    8 Site US10001 Aurora Colorado United States 80045
    9 Site US10017 Denver Colorado United States 80211
    10 Site US10050 Washington District of Columbia United States 20037
    11 Site US10049 Daytona Beach Florida United States 32114
    12 Site US10048 Jacksonville Florida United States 32216
    13 Site US10002 Chicago Illinois United States 60637
    14 Site US10007 Jeffersonville Indiana United States 47130
    15 Site US10029 Towson Maryland United States 21204
    16 Site US10032 Saint Louis Missouri United States 63110
    17 Site US10023 Omaha Nebraska United States 68130
    18 Site US10004 Hackensack New Jersey United States 07601
    19 Site US10024 Garden City New York United States 11530
    20 Site US10055 New York New York United States 10065
    21 Site US10059 New York New York United States 10065
    22 Site US10053 Syracuse New York United States 13210
    23 Site US10030 Chapel Hill North Carolina United States 27599
    24 Site US10062 Charlotte North Carolina United States 28207
    25 Site US10020 Concord North Carolina United States 28025
    26 Site US10031 Greensboro North Carolina United States 27403
    27 Site US10046 Winston-Salem North Carolina United States 27157
    28 Site US10035 Cincinnati Ohio United States 45212
    29 Site US10022 Springfield Oregon United States 97477
    30 Site US10027 Lancaster Pennsylvania United States 17604
    31 Site US10005 Pittsburgh Pennsylvania United States 15232
    32 Site US10018 Charleston South Carolina United States 29414
    33 Site US10003 Myrtle Beach South Carolina United States 29572
    34 Site US10041 Nashville Tennessee United States 37232-2765
    35 Site US10010 Dallas Texas United States 75231
    36 Site US10034 Houston Texas United States 77024
    37 Site US10043 Houston Texas United States 77030
    38 Site US10014 Norfolk Virginia United States 23502
    39 Site US10015 Virginia Beach Virginia United States 23462
    40 Site US10038 Seattle Washington United States 98109
    41 Site US10021 Madison Wisconsin United States 53792
    42 Site AR54005 Buenos Aires Caba Argentina C1120AAT
    43 Site AR54003 Cordorba Argentina
    44 Site AR54002 Tucuman Argentina
    45 Site AU61001 Tweed Heads New South Wales Australia 2485
    46 Site AU61006 Ashford Australia
    47 Site AU61009 Malvern Australia
    48 Site AU61008 South Brisbane Australia
    49 Site AU61004 Westmead Australia 2145
    50 Site AU61004 Westmead Australia
    51 Site BE32002 Kortrijk West-Vlaanderen Belgium 8500
    52 Site BE32004 Brussels Belgium B-1090
    53 Site BE32005 Gent Belgium 9000
    54 Site BE32011 Gent Belgium 9000
    55 Site BE32007 Hasselt Belgium
    56 Site BE32008 Leuven Belgium 3000
    57 Site BE32001 Liege Belgium 4000
    58 Site BE32003 Turnhout Belgium 2300
    59 Site CA15003 Kingston Ontario Canada K7L 3J7
    60 Site CA15001 Granby Quebec Canada J2G 8Z9
    61 Site CA15011 Montreal Canada
    62 Site CL56004 IX Region Chile
    63 Site CL56002 Santiago Chile
    64 Site CL56001 Vina del Mar Chile
    65 Site CZ42002 Olomouc Czechia 779 00
    66 Site CZ42003 Praha 2 Czechia
    67 Site CZ42001 Praha 6 Czechia 16000
    68 Site DK45002 Aalborg Nordjylland Denmark 9000
    69 Site DK45003 Aarhus Denmark 8200
    70 Site DK45001 Copenhagen Denmark 2100
    71 Site DK45004 Herlev Denmark 2730
    72 Site FL35802 Tampere Finland
    73 Site FR33008 La Roche sur Yon France 85925
    74 Site FR33010 Lille France 59037
    75 Site FR33002 Lyon Cedex 3 France 69003
    76 Site FR33006 Nimes France 30029
    77 Site FR33003 Paris France
    78 Site FR33017 Paris France
    79 Site FR33001 Saint Herblain France
    80 Site FR33019 Strasbourg France 67000
    81 Site FR33004 Villejuif France
    82 Site GE99501 Tbilisi Georgia GE- 0186
    83 Site DE49004 Nürtingen Baden-Württemberg Germany 72622
    84 Site DE49007 Waldshut-Tiengen Baden-Württemberg Germany 79761
    85 Site DE49006 Mannheim DE Germany 68167
    86 Site DE49001 Duisburg NRW Germany 47179
    87 Site DE49010 Bonn Germany 53111
    88 Site DE49003 Hamburg Germany 22081
    89 Site DE49013 Hamburg Germany
    90 Site IL97202 Peth Tikva Israel
    91 Site IL97204 Ramat-Gan Israel
    92 Site IL97203 Tzrifin Beer Yakov Israel
    93 Site IT39001 Arezzo Italy
    94 Site IT39004 Cremona Italy
    95 Site IT39002 Forli Italy
    96 Site IT39005 Roma Italy
    97 Site KR82005 Seongnam-si Korea, Republic of
    98 Site KR82001 Seoul Korea, Republic of
    99 Site KR82002 Seoul Korea, Republic of
    100 Site KR82003 Seoul Korea, Republic of
    101 Site KR82004 Seoul Korea, Republic of
    102 Site MD37301 Chisinau Moldova, Republic of
    103 Site NZ64001 Hamilton New Zealand
    104 Site PL48002 Gdansk Poland
    105 Site PL48001 Myslowice Poland
    106 Site PL48004 Pozman Poland
    107 Site PL48003 Wroclaw Poland
    108 Site RU70001 Moscow Russian Federation
    109 Site RU70003 St. Petersburg Russian Federation
    110 Site SK10223 Bratislava Slovakia
    111 Site SK42105 Nitra Slovakia 949 01
    112 Site ZA27001 George South Africa 6529
    113 Site ES34003 Barcelona Spain
    114 Site ES34004 Barcelona Spain
    115 Site ES34001 Madrid Spain 28034
    116 Site ES34005 Pamplona Spain
    117 Site SE46001 Göteborg Sweden 41345
    118 Site SE46003 Umeå Sweden 90185
    119 Site GB44009 Bebington United Kingdom
    120 Site GB44003 Belfast United Kingdom
    121 Site GB44004 Bristol United Kingdom BS28HW
    122 Site GB44005 Cardiff United Kingdom CF4 4XN
    123 Site GB44002 Glasgow United Kingdom
    124 Site GB44006 London United Kingdom
    125 Site GB44007 Manchester United Kingdom M20 4BX
    126 Site GB44008 Northwood United Kingdom
    127 Site GB44001 Sutton United Kingdom

    Sponsors and Collaborators

    • Astellas Pharma Global Development, Inc.
    • Pfizer

    Investigators

    • Study Director: Associate Medical Director, Astellas Pharma Global Development, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Astellas Pharma Global Development, Inc.
    ClinicalTrials.gov Identifier:
    NCT02960022
    Other Study ID Numbers:
    • 9785-CL-0123
    • 2016-001694-32
    First Posted:
    Nov 9, 2016
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Astellas Pharma Global Development, Inc.
    prostate cancer
    prednisone
    MDV3100
    enzalutamide
    Xtandi
    abiraterone acetate
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Prednisone
    Abiraterone Acetate

    Study Results

    No Results Posted as of Aug 24, 2022