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

• ClinicalTrials.gov Identifier: NCT02960022
• Recruitment Status: Recruiting
• First Posted: November 9, 2016
• Last Update Posted: March 9, 2021
• Sponsor: Astellas Pharma Global Development, Inc.
• Collaborator: Pfizer
• Information provided by (Responsible Party): Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Tracking Information

• First Submitted Date: November 7, 2016
• First Posted Date: November 9, 2016
• Last Update Posted Date: March 9, 2021
• Actual Study Start Date: December 22, 2016
• Estimated Primary Completion Date: April 18, 2024 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 21, 2017): Number of participants with adverse events [ Time Frame: Until End of Study (Up to 44 Months) ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 5, 2021): 900
• Original Enrollment: Not Provided
• Estimated Study Completion Date: April 18, 2024
• Estimated Primary Completion Date: April 18, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Astellas Pharma Global Development; 800-888-7704; astellas.registration@astellas.com

• Listed Location Countries: 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

Administrative Information

• NCT Number: NCT02960022
• Other Study ID Numbers: 9785-CL-0123; 2016-001694-32 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: Astellas Pharma Global Development, Inc.
• Collaborators: Pfizer

Investigators

• Study Director: Associate Medical Director; Astellas Pharma Global Development, Inc.

• PRS Account: Astellas Pharma Inc
• Verification Date: February 2021