Clinical trial NCT02960022: A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Official title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
prednisone
MDV3100
enzalutamide
Xtandi
abiraterone acetate
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2016-11-09
Enrollment: 900
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Canada Specific:

* Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures.
* Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer 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 they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., 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 is either:
* Of nonchildbearing potential:
* postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age),
* documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1),
* Or, if of childbearing potential,
* must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered,
* must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration,
* must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration.

The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods:

* A barrier method (e.g., condom by a male partner) is required; AND
* One of the following is required:
* Placement of an intrauterine device (IUD) or intrauterine system (IUS);
* Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
* Vasectomy or other surgical castration at least 6 months before Day 1.
* The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug 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.

Canada Specific:

Subject will be excluded from participation if any of the following apply:

* Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
* Subject requires treatment with or plans to use any of the following:
* New systemic therapy for their 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 in the opinion of the investigator.

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: Until End of Study (Up to 96 Months)
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Site US10052
state: Alaska
city: Tucson
country: United States
facility: Site US10011
state: Arizona
city: Los Angeles
country: United States
facility: Site US10040
state: California
city: Los Angeles
country: United States
facility: Site US10009
state: California
city: Orange
country: United States
facility: Site US10067
state: California
city: San Bernardino
country: United States
facility: Site US10008
state: California
city: San Diego
country: United States
facility: Site US10042
state: California
city: Stanford
country: United States
facility: Site US10028
state: California
city: Aurora
country: United States
facility: Site US10001
state: Colorado
city: Denver
country: United States
facility: Site US10017
state: Colorado
city: Washington
country: United States
facility: Site US10050
state: District of Columbia
city: Daytona Beach
country: United States
facility: Site US10049
state: Florida
city: Jacksonville
country: United States
facility: Site US10048
state: Florida
city: Chicago
country: United States
facility: Site US10002
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Jeffersonville
country: United States
facility: Site US10007
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lenexa
country: United States
facility: Site US10066
state: Kansas
city: Towson
country: United States
facility: Site US10029
state: Maryland
city: Saint Louis
country: United States
facility: Site US10032
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medical Hospital
state: Nebraska
city: Omaha
country: United States
facility: Site US10023
state: Nebraska
city: Hackensack
country: United States
facility: Site US10004
state: New Jersey
city: Garden City
country: United States
facility: Site US10024
state: New York
city: New York
country: United States
facility: Site US10055
state: New York
city: New York
country: United States
facility: Site US10059
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Syracuse
country: United States
facility: Site US10053
state: New York
city: Chapel Hill
country: United States
facility: Site US10030
state: North Carolina
city: Charlotte
country: United States
facility: Site US10062
state: North Carolina
city: Concord
country: United States
facility: Site US10020
state: North Carolina
city: Greensboro
country: United States
facility: Site US10031
state: North Carolina
city: Greenville
country: United States
facility: Eastern Urological Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Site US10046
state: North Carolina
city: Cincinnati
country: United States
facility: Site US10035
state: Ohio
city: Springfield
country: United States
facility: Site US10022
state: Oregon
city: Lancaster
country: United States
facility: Site US10027
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Site US10005
state: Pennsylvania
city: Charleston
country: United States
facility: Site US10018
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Site US10003
state: South Carolina
city: Nashville
country: United States
facility: Site US10041
state: Tennessee
city: Dallas
country: United States
facility: Site US10010
state: Texas
city: Houston
country: United States
facility: Site US10034
state: Texas
city: Houston
country: United States
facility: Site US10043
state: Texas
city: Norfolk
country: United States
facility: Site US10014
state: Virginia
city: Virginia Beach
country: United States
facility: Site US10015
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Site US10038
state: Washington
city: Madison
country: United States
facility: Site US10021
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Site AR54005
state: Caba
city: Rosario
country: Argentina
facility: Site AR54007
state: Santa Fé
city: Buenos Aires
country: Argentina
facility: Site AR54008
city: Cordorba
country: Argentina
facility: Site AR54003
city: San Miguel de Tucuman
country: Argentina
facility: Site AR54006
city: Tucuman
country: Argentina
facility: Site AR54002
city: Albury
country: Australia
facility: Site AU61014
state: New South Wales
city: Tweed Heads
country: Australia
facility: Site AU61001
state: New South Wales
city: Wahroonga
country: Australia
facility: Site AU61012
state: New South Wales
city: Wahroonga
country: Australia
facility: Site AU61017
state: New South Wales
city: Ashford
country: Australia
facility: Site AU61006
city: Ballarat
country: Australia
facility: Site AU61019
city: East Bentleigh
country: Australia
facility: Site AU61007
city: Malvern
country: Australia
facility: Site AU61009
city: Parkville
country: Australia
facility: Site AU61021
city: South Brisbane
country: Australia
facility: Site AU61008
city: St Albans
country: Australia
facility: Site AU61016
city: Westmead
country: Australia
facility: Site AU61004
city: Vienna
country: Austria
facility: Site AT43001
city: Kortrijk
country: Belgium
facility: Site BE32002
state: West-Vlaanderen
city: Anderlecht
country: Belgium
facility: Site BE32009
city: Brussels
country: Belgium
facility: Site BE32004
city: Gent
country: Belgium
facility: Site BE32005
city: Gent
country: Belgium
facility: Site BE32011
city: Hasselt
country: Belgium
facility: Site BE32007
city: Leuven
country: Belgium
facility: Site BE32008
city: Liege
country: Belgium
facility: Site BE32001
city: Turnhout
country: Belgium
facility: Site BE32003
city: Porto Alegre
country: Brazil
facility: Site BR55007
state: RIO Grande DO SUL
city: Bahia
country: Brazil
facility: Site BR55009
city: Campinas
country: Brazil
facility: Site BR55008
city: Ijuí
country: Brazil
facility: Site BR55004
city: Jau
country: Brazil
facility: Site BR55011
city: Rio Grande Do Sul
country: Brazil
facility: Site BR55002
city: Santo Andre
country: Brazil
facility: Site BR55010
city: Kingston
country: Canada
facility: Site CA15003
state: Ontario
city: Toronto
country: Canada
facility: Site CA15021
state: Ontario
city: Granby
country: Canada
facility: Site CA15001
state: Quebec
city: Abbotsford
country: Canada
facility: Site CA15019
city: Greenville
country: Canada
facility: Site CA15020
city: Montreal
country: Canada
facility: Site CA15011
city: Oakville
country: Canada
facility: Site CA15017
city: Quebec
country: Canada
facility: Site CA15022
city: Santiago
country: Chile
facility: Site CL56007
state: RM
city: Santiago
country: Chile
facility: Site CL56005
state: RM
city: Vina Del Mar
country: Chile
facility: Site CL56006
state: Valparaiso
city: IX Region
country: Chile
facility: Site CL56004
city: Santiago
country: Chile
facility: Site CL56002
city: Vina del Mar
country: Chile
facility: Site CL56001
city: Hubei
country: China
facility: Site CN86003
city: Hunan
country: China
facility: Site CN86010
city: Nanjing
country: China
facility: Site CN86005
city: Olomouc
country: Czechia
facility: Site CZ42004
city: Olomouc
country: Czechia
facility: Site CZ42002
city: Praha 2
country: Czechia
facility: Site CZ42003
city: Praha 6
country: Czechia
facility: Site CZ42001
city: Aalborg
country: Denmark
facility: Site DK45002
state: Nordjylland
city: Aarhus
country: Denmark
facility: Site DK45003
city: Copenhagen
country: Denmark
facility: Site DK45001
city: Herlev
country: Denmark
facility: Site DK45004
city: Vejle
country: Denmark
facility: Site DK45006
city: Tampere
country: Finland
facility: Site FL35802
city: Turku
country: Finland
facility: Site FL35805
city: Bordeaux Cedex
country: France
facility: Site FR33021
city: La Roche sur Yon
country: France
facility: Site FR33008
city: Lille
country: France
facility: Site FR33010
city: Lyon Cedex 3
country: France
facility: Site FR33002
city: Montpellier Cedex
country: France
facility: Site FR33020
city: Nimes
country: France
facility: Site FR33006
city: Paris
country: France
facility: Site FR33003
city: Paris
country: France
facility: Site FR33017
city: Saint Herblain
country: France
facility: Site FR33001
city: Strasbourg
country: France
facility: Site FR33019
city: Strasbourg
country: France
facility: Site FR33022
city: Villejuif
country: France
facility: Site FR33004
city: Tbilisi
country: Georgia
facility: Site GE99501
city: Nürtingen
country: Germany
facility: Site DE49004
state: Baden-Württemberg
city: Waldshut-Tiengen
country: Germany
facility: Site DE49007
state: Baden-Württemberg
city: Mannheim
country: Germany
facility: Site DE49006
state: DE
city: Duisburg
country: Germany
facility: Site DE49001
state: NRW
city: Bonn
country: Germany
facility: Site DE49010
city: Hamburg
country: Germany
facility: Site DE49003
city: Hamburg
country: Germany
facility: Site DE49013
city: Hong Kong
country: Hong Kong
facility: Site HK85202
city: Haifa
country: Israel
facility: Site IL97206
city: Jerusalem
country: Israel
facility: Site IL97205
city: Peth Tikva
country: Israel
facility: Site IL97202
city: Ramat-Gan
country: Israel
facility: Site IL97204
city: Tzrifin Beer Yakov
country: Israel
facility: Site IL97203
city: Faenza (RA)
country: Italy
facility: Site IT39008
state: Emilia Romagna
city: Arezzo
country: Italy
facility: Site IT39001
city: Candiolo
country: Italy
facility: Site IT39011
city: Cremona
country: Italy
facility: Site IT39004
city: Forli
country: Italy
facility: Site IT39002
city: Roma
country: Italy
facility: Site IT39005
city: Toscana
country: Italy
facility: Site IT39009
city: Trento
country: Italy
facility: Site IT39006
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Higashi-ku
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Kida-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Medical Center
state: Kanagawa
city: Sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Koutou-ku
country: Japan
facility: The Cancer Institute Hospital of Japanese Foundation for Cancer Research
state: Tokyo
city: Ube
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi
city: Chiba
country: Japan
facility: Chiba cancer center
city: Fukuoka
country: Japan
facility: Harasanshin hospital
city: Kyoto
country: Japan
facility: Kyoto University hospital
city: Niigata
country: Japan
facility: Niigata University Medical and Dental Hospital
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital
city: Busan
country: Korea, Republic of
facility: Site KR82008
city: Seongnam-si
country: Korea, Republic of
facility: Site KR82012
city: Seongnam-si
country: Korea, Republic of
facility: Site KR82005
city: Seoul
country: Korea, Republic of
facility: Site KR82009
city: Seoul
country: Korea, Republic of
facility: Site KR82007
city: Seoul
country: Korea, Republic of
facility: Site KR82011
city: Seoul
country: Korea, Republic of
facility: Site KR82001
city: Seoul
country: Korea, Republic of
facility: Site KR82002
city: Seoul
country: Korea, Republic of
facility: Site KR82003
city: Seoul
country: Korea, Republic of
facility: Site KR82004
city: Kuching
country: Malaysia
facility: Site MY60001
city: Chisinau
country: Moldova, Republic of
facility: Site MD37301
city: Amsterdam
country: Netherlands
facility: Site NL31010
city: Den Helder
country: Netherlands
facility: Site NL31009
city: Maastricht
country: Netherlands
facility: Site NL31004
city: Rotterdam
country: Netherlands
facility: Site NL31011
city: Auckland
country: New Zealand
facility: Site NZ64002
city: Dunedin
country: New Zealand
facility: Site NZ64005
city: Hamilton
country: New Zealand
facility: Site NZ64001
city: Stavanger
country: Norway
facility: Site NO47001
city: Gdansk
country: Poland
facility: Site PL48002
city: Myslowice
country: Poland
facility: Site PL48001
city: Pozman
country: Poland
facility: Site PL48004
city: Slupsk
country: Poland
facility: Site PL48005
city: Wrocław
country: Poland
facility: Site PL48003
city: Bucuresti
country: Romania
facility: Site RO40003
city: Cluj
country: Romania
facility: Site RO40001
city: Cluj
country: Romania
facility: Site RO40004
city: Ivanovo
country: Russian Federation
facility: Site RU70008
city: Moscow
country: Russian Federation
facility: Site RU70001
city: Omsk
country: Russian Federation
facility: Site RU70005
city: St. Petersburg
country: Russian Federation
facility: Site RU70009
city: St. Petersburg
country: Russian Federation
facility: Site RU70003
city: St. Petersburg
country: Russian Federation
facility: Site RU70006
city: Belgrade
country: Serbia
facility: Site RS38102
city: Belgrade
country: Serbia
facility: Site RS38101
city: Bratislava
country: Slovakia
facility: Site SK10223
city: Kosice
country: Slovakia
facility: Site SK42109
city: Kosice
country: Slovakia
facility: Site SK42106
city: Nitra
country: Slovakia
facility: Site SK42105
city: Presov
country: Slovakia
facility: Site SK42103
city: Trencin
country: Slovakia
facility: Site SK42108
city: Zilina
country: Slovakia
facility: Site SK42107
city: George
country: South Africa
facility: Site ZA27001
city: Barcelona
country: Spain
facility: Site ES34007
city: Barcelona
country: Spain
facility: Site ES34003
city: Barcelona
country: Spain
facility: Site ES34004
city: Gerona
country: Spain
facility: Site ES34011
city: Madrid
country: Spain
facility: Site ES34012
city: Madrid
country: Spain
facility: Site ES34001
city: Madrid
country: Spain
facility: Site ES34008
city: Pamplona
country: Spain
facility: Site ES34005
city: Salamanca
country: Spain
facility: Site ES34014
city: Santiago de Compostela
country: Spain
facility: Site ES34010
city: Göteborg
country: Sweden
facility: Site SE46001
city: Umeå
country: Sweden
facility: Site SE46003
city: Gueishan
country: Taiwan
facility: Site TW88607
city: Kaohsiung
country: Taiwan
facility: Site TW88603
city: Kaohsiung
country: Taiwan
facility: Site TW88601
city: Taichung
country: Taiwan
facility: Site TW88602
city: Taipei
country: Taiwan
facility: Site TW88606
city: Hat Yai
country: Thailand
facility: Site TH66001
state: Songkla
city: Bangkok
country: Thailand
facility: Site TH66002
city: Besevler
country: Turkey
facility: Site TR90002
state: Ankara
city: Bebington
country: United Kingdom
facility: Site GB44009
city: Belfast
country: United Kingdom
facility: Site GB44003
city: Bristol
country: United Kingdom
facility: Site GB44004
city: Cambridge
country: United Kingdom
facility: Site GB44014
city: Cardiff
country: United Kingdom
facility: Site GB44005
city: Glasgow
country: United Kingdom
facility: Site GB44002
city: London
country: United Kingdom
facility: Site GB44006
city: Manchester
country: United Kingdom
facility: Site GB44007
city: Northwood
country: United Kingdom
facility: Site GB44008
city: Nottingham
country: United Kingdom
facility: Site GB44016
city: Sutton
country: United Kingdom
facility: Site GB44001
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Associate Medical Director
role: STUDY_DIRECTOR
References: