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Recruiting Phase 2 NCT02960022

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

Phase 2 – studying effectiveness and dosage
Conditions: Prostate Cancer

Sponsor: Astellas Pharma Global Development, Inc.

trial.available_in: БГ
Overview
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) unless the subject is on treatment suspension. 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. After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.
Who can participate
Inclusion Criteria: * Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) 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 they were receiving or were assigned to receive 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.
Locations 36
Argentina (1)
Site AR54005
Buenos Aires , Buenos Aires F.D.
COMPLETED
Australia (1)
Site AU61014
Albury , New South Wales
COMPLETED
Belgium (1)
Site BE32002
Kortrijk , West-Vlaanderen
ACTIVE_NOT_RECRUITING
Brazil (1)
Site BR55007
Porto Alegre , Rio Grande do Sul
ACTIVE_NOT_RECRUITING
Canada (1)
Site CA15003
Kingston , Ontario
COMPLETED
Chile (1)
Site CL56007
Santiago , RM
ACTIVE_NOT_RECRUITING
China (1)
Site CN86003
Hubei
ACTIVE_NOT_RECRUITING
Czech Republic (1)
Site CZ42004
Olomouc
ACTIVE_NOT_RECRUITING
Denmark (1)
Site DK45002
Aalborg , North Denmark
ACTIVE_NOT_RECRUITING
Finland (1)
Site FL35802
Tampere
ACTIVE_NOT_RECRUITING
France (1)
Site FR33021
Bordeaux
COMPLETED
Georgia (1)
Site GE99501
Tbilisi
COMPLETED
Hong Kong (1)
Site HK85202
Hong Kong
ACTIVE_NOT_RECRUITING
Israel (1)
Site IL97206
Haifa
Italy (1)
Site IT39008
Faenza (RA) , Emilia-Romagna
ACTIVE_NOT_RECRUITING
Japan (1)
Toho University Sakura Medical Center
Sakura-shi , Chiba
ACTIVE_NOT_RECRUITING
Malaysia (1)
Site MY60001
Kuching
COMPLETED
Moldova (1)
Site MD37301
Chisinau
ACTIVE_NOT_RECRUITING
Netherlands (1)
Site NL31010
Amsterdam
ACTIVE_NOT_RECRUITING
New Zealand (1)
Site NZ64002
Auckland
ACTIVE_NOT_RECRUITING
Norway (1)
Site NO47001
Stavanger
ACTIVE_NOT_RECRUITING
Poland (1)
Site PL48002
Gdansk
ACTIVE_NOT_RECRUITING
Romania (1)
Site RO40003
Bucharest
ACTIVE_NOT_RECRUITING
Russia (1)
Site RU70008
Ivanovo
ACTIVE_NOT_RECRUITING
Serbia (1)
Site RS38102
Belgrade
COMPLETED
Slovakia (1)
Site SK10223
Bratislava
ACTIVE_NOT_RECRUITING
South Africa (1)
Site ZA27001
George
COMPLETED
South Korea (1)
Site KR82008
Busan
ACTIVE_NOT_RECRUITING
Spain (1)
Site ES34007
Barcelona
COMPLETED
Sweden (1)
Site SE46001
Gothenburg
COMPLETED
Taiwan (1)
Site TW88607
Guishan
ACTIVE_NOT_RECRUITING
Thailand (1)
Site TH66001
Hat Yai , Changwat Songkhla
ACTIVE_NOT_RECRUITING
Turkey (1)
Site TR90002
Beşevler , Ankara
ACTIVE_NOT_RECRUITING
Ukraine (1)
Site UA38004
Dnipro
ACTIVE_NOT_RECRUITING
United Kingdom (1)
Site GB44009
Bebington
COMPLETED
United States (1)
Site US10052
Anchorage , Alaska
COMPLETED
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male only
Minimum age
18 Years
Healthy volunteers
No
Start date
22.12.2016
Completion date
31.07.2029
Registry ID
NCT02960022
Source
anzctr
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