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

Prostate Cancer Clinical Trial

Official title:

A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960022
• Other study ID #: 9785-CL-0123
• Secondary ID: 2016-001694-32jR
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2016
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: Astellas Pharma Inc
• Contact: Astellas Pharma Global Development
• Phone: 800-888-7704
• Email: astellas.registration[@]astellas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day.
• 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
• 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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.	Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Czechia,  Denmark,  Finland,  France,  Georgia,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Moldova, Republic of,  Netherlands,  New Zealand,  Norway,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		Until End of Study (Up to 96 Months)