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

NCT02960022

Last updated date
Study Location
Site SE46001
Göteborg, , 41345, Sweden
Contact
800-888-7704

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Official Title  ICMJE A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: enzalutamide
    Subjects will receive enzalutamide orally once daily at the same time each day
    Intervention: Drug: enzalutamide
  • 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
    Interventions:
    • Drug: enzalutamide
    • Drug: abiraterone acetate
    • Drug: prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2017)
470
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Astellas Pharma Global Development800-888-7704[email protected]
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Chile,   Czechia,   Denmark,   Finland,   France,   Georgia,   Germany,   Israel,   Italy,   Korea, Republic of,   Moldova, Republic of,   New Zealand,   Poland,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02960022
Other Study ID Numbers  ICMJE 9785-CL-0123
2016-001694-32 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description: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 compounds 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. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (CSR)
Time Frame: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.
Access Criteria: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.
URL:https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Associate Medical DirectorAstellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP