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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: enzalutamide; Drug: abiraterone acetate; Drug: prednisone	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	470 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Actual Study Start Date :	December 22, 2016
Estimated Primary Completion Date :	July 2021
Estimated Study Completion Date :	July 2021

Arms and Interventions

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Arm	Intervention/treatment
Experimental: enzalutamide; Subjects will receive enzalutamide orally once daily at the same time each day	Drug: enzalutamide; Subjects will receive enzalutamide orally once daily at the same time each day.; Other Names: MDV3100; Xtandi
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	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

Outcome Measures

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Primary Outcome Measures :

1. Number of participants with adverse events [ Time Frame: Until End of Study (Up to 44 Months) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Contacts

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

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Sponsors and Collaborators

Astellas Pharma Global Development, Inc.

Pfizer

Investigators

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

More Information

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Responsible Party:	Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier:	NCT02960022 History of Changes
Other Study ID Numbers:	9785-CL-0123; 2016-001694-32 ( EudraCT Number )
First Posted:	November 9, 2016
Last Update Posted:	May 8, 2018
Last Verified:	May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

prostate cancer; prednisone; MDV3100	enzalutamide; Xtandi; abiraterone acetate

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Prednisone; Abiraterone Acetate; Anti-Inflammatory Agents; Glucocorticoids	Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors