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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02960022




Registration number
NCT02960022
Ethics application status
Date submitted
7/11/2016
Date registered
9/11/2016

Titles & IDs
Public title
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Scientific title
A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Secondary ID [1] 0 0
2016-001694-32
Secondary ID [2] 0 0
9785-CL-0123
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - enzalutamide
Treatment: Drugs - abiraterone acetate
Treatment: Drugs - prednisone

Experimental: enzalutamide - Subjects will receive enzalutamide orally once daily at the same time each day

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


Treatment: Drugs: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day.

Treatment: Drugs: 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

Treatment: Drugs: 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
Until End of Study (Up to 96 Months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/07/2026
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Site AU61014 - Albury
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Site AU61001 - Tweed Heads
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Site AU61012 - Wahroonga
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Site AU61017 - Wahroonga
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Site AU61006 - Ashford
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Site AU61019 - Ballarat
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Site AU61007 - East Bentleigh
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Site AU61009 - Malvern
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Site AU61021 - Parkville
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Site AU61008 - South Brisbane
Recruitment hospital [11] 0 0
Site AU61016 - St Albans
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Site AU61004 - Westmead
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2640 - Albury
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2485 - Tweed Heads
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2076 - Wahroonga
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- Ashford
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3350 - Ballarat
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3165 - East Bentleigh
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- Malvern
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- Parkville
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- South Brisbane
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3021 - St Albans
Recruitment postcode(s) [11] 0 0
2145 - Westmead
Recruitment outside Australia
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Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Associate Medical Director
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Astellas Pharma Global Development
Address 0 0
Country 0 0
Phone 0 0
800-888-7704
Fax 0 0
Email 0 0
astellas.registration@astellas.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicaltrials.astellas.com/transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02960022