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
122
Locations
2
Arms
95.3
Anticipated Duration (Months)
7.4
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 DiseaseIntervention/TreatmentPhase
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.

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

ArmIntervention/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

    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

    SiteCityStateCountryPostal Code
    1Site US10052AnchorageAlaskaUnited States99503
    2Site US10011TucsonArizonaUnited States85741
    3Site US10040Los AngelesCaliforniaUnited States90024
    4Site US10009Los AngelesCaliforniaUnited States90048
    5Site US10008San BernardinoCaliforniaUnited States92404
    6Site US10042San DiegoCaliforniaUnited States92108
    7Site US10028StanfordCaliforniaUnited States94305
    8Site US10001AuroraColoradoUnited States80045
    9Site US10017DenverColoradoUnited States80211
    10Site US10050WashingtonDistrict of ColumbiaUnited States20037
    11Site US10049Daytona BeachFloridaUnited States32114
    12Site US10048JacksonvilleFloridaUnited States32216
    13Site US10002ChicagoIllinoisUnited States60637
    14Site US10007JeffersonvilleIndianaUnited States47130
    15Site US10029TowsonMarylandUnited States21204
    16Site US10032Saint LouisMissouriUnited States63110
    17Site US10023OmahaNebraskaUnited States68130
    18Site US10004HackensackNew JerseyUnited States07601
    19Site US10024Garden CityNew YorkUnited States11530
    20Site US10055New YorkNew YorkUnited States10065
    21Site US10059New YorkNew YorkUnited States10065
    22Site US10053SyracuseNew YorkUnited States13210
    23Site US10030Chapel HillNorth CarolinaUnited States27599
    24Site US10062CharlotteNorth CarolinaUnited States28207
    25Site US10020ConcordNorth CarolinaUnited States28025
    26Site US10031GreensboroNorth CarolinaUnited States27403
    27Site US10046Winston-SalemNorth CarolinaUnited States27157
    28Site US10035CincinnatiOhioUnited States45212
    29Site US10022SpringfieldOregonUnited States97477
    30Site US10027LancasterPennsylvaniaUnited States17604
    31Site US10005PittsburghPennsylvaniaUnited States15232
    32Site US10018CharlestonSouth CarolinaUnited States29414
    33Site US10003Myrtle BeachSouth CarolinaUnited States29572
    34Site US10041NashvilleTennesseeUnited States37232-2765
    35Site US10010DallasTexasUnited States75231
    36Site US10034HoustonTexasUnited States77024
    37Site US10043HoustonTexasUnited States77030
    38Site US10014NorfolkVirginiaUnited States23502
    39Site US10015Virginia BeachVirginiaUnited States23462
    40Site US10038SeattleWashingtonUnited States98109
    41Site US10021MadisonWisconsinUnited States53792
    42Site AR54003CordorbaArgentina
    43Site AR54002TucumanArgentina
    44Site AU61001Tweed HeadsNew South WalesAustralia2485
    45Site AU61006AshfordAustralia
    46Site AU61009MalvernAustralia
    47Site AU61008South BrisbaneAustralia
    48Site AU61004WestmeadAustralia
    49Site BE32002KortrijkWest-VlaanderenBelgium8500
    50Site BE32004BrusselsBelgiumB-1090
    51Site BE32005GentBelgium9000
    52Site BE32007HasseltBelgium
    53Site BE32008LeuvenBelgium3000
    54Site BE32001LiegeBelgium4000
    55Site BE32003TurnhoutBelgium2300
    56Site CA15003KingstonOntarioCanadaK7L 3J7
    57Site CA15001GranbyQuebecCanadaJ2G 8Z9
    58Site CA15011MontrealCanada
    59Site CL56004IX RegionChile
    60Site CL56002SantiagoChile
    61Site CL56001Vina del MarChile
    62Site CZ42002OlomoucCzechia779 00
    63Site CZ42003Praha 2Czechia
    64Site CZ42001Praha 6Czechia16000
    65Site DK45002AalborgNordjyllandDenmark9000
    66Site DK45003AarhusDenmark8200
    67Site DK45001CopenhagenDenmark2100
    68Site DK45004HerlevDenmark2730
    69Site FL35802TampereFinland
    70Site FR33008La Roche sur YonFrance85925
    71Site FR33010LilleFrance59037
    72Site FR33002Lyon Cedex 3France69003
    73Site FR33006NimesFrance30029
    74Site FR33003ParisFrance
    75Site FR33017ParisFrance
    76Site FR33001Saint HerblainFrance
    77Site FR33004VillejuifFrance
    78Site GE99501TbilisiGeorgiaGE- 0186
    79Site DE49004NürtingenBaden-WürttembergGermany72622
    80Site DE49007Waldshut-TiengenBaden-WürttembergGermany79761
    81Site DE49006MannheimDEGermany68167
    82Site DE49001DuisburgNRWGermany47179
    83Site DE49010BonnGermany53111
    84Site DE49003HamburgGermany22081
    85Site DE49013HamburgGermany
    86Site IL97202Peth TikvaIsrael
    87Site IL97204Ramat-GanIsrael
    88Site IL97203Tzrifin Beer YakovIsrael
    89Site IT39001ArezzoItaly
    90Site IT39004CremonaItaly
    91Site IT39002ForliItaly
    92Site IT39005RomaItaly
    93Site KR82005Seongnam-siKorea, Republic of
    94Site KR82001SeoulKorea, Republic of
    95Site KR82002SeoulKorea, Republic of
    96Site KR82003SeoulKorea, Republic of
    97Site KR82004SeoulKorea, Republic of
    98Site MD37301ChisinauMoldova, Republic of
    99Site NZ64001HamiltonNew Zealand
    100Site PL48002GdanskPoland
    101Site PL48001MyslowicePoland
    102Site PL48004PozmanPoland
    103Site PL48003WroclawPoland
    104Site RU70001MoscowRussian Federation
    105Site RU70003St. PetersburgRussian Federation
    106Site SK10223BratislavaSlovakia
    107Site ZA27001GeorgeSouth Africa6529
    108Site ES34003BarcelonaSpain
    109Site ES34004BarcelonaSpain
    110Site ES34001MadridSpain28034
    111Site ES34005PamplonaSpain
    112Site SE46001GöteborgSweden41345
    113Site SE46003UmeåSweden90185
    114Site GB44009BebingtonUnited Kingdom
    115Site GB44003BelfastUnited Kingdom
    116Site GB44004BristolUnited KingdomBS28HW
    117Site GB44005CardiffUnited KingdomCF4 4XN
    118Site GB44002GlasgowUnited Kingdom
    119Site GB44006LondonUnited Kingdom
    120Site GB44007ManchesterUnited KingdomM20 4BX
    121Site GB44008NorthwoodUnited Kingdom
    122Site GB44001SuttonUnited 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:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    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.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 1, 2021