Save

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

PHASE2RECRUITING

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.

Simpliy with AI

Study details:

Subjects must 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 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to 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.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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 or, if of childbearing potential, must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered.

Subject must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration.

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.

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.

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.

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Male

Things to know

Study dates

Study start: 2016-12-22

Primary completion: 2026-07-31

Study completion finish: 2026-07-31

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT02960022

Intervention or treatment

DRUG: enzalutamide

DRUG: abiraterone acetate

DRUG: prednisone

Conditions

• Prostate Cancer

Condition: Prostate Cancer
DRUG: enzalutamide and other drugs
Albury, New South Wales, Australia and more
Sponsor: Astellas Pharma Global Development, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Site AU61014

Research sites nearby

Select from list below to view details:

Site AU61014
Albury, New South Wales, Australia
Site AU61001
Tweed Heads, New South Wales, Australia
Site AU61012
Wahroonga, New South Wales, Australia
Site AU61017
Wahroonga, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/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.
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	DRUG: enzalutamide Subjects will receive enzalutamide orally once daily at the same time each day.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants with adverse events	Not Specified	Until End of Study (Up to 96 Months)

Secondary outcome

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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