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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02960022
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : April 8, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information
First Submitted Date  ICMJE November 7, 2016
First Posted Date  ICMJE November 9, 2016
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE December 22, 2016
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2017)
Number of participants with adverse events [ Time Frame: Until End of Study (Up to 44 Months) ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT02960022 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Development 800-888-7704 astellas.registration@astellas.com
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,   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: Undecided
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 Director Astellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date April 2019

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