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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Astellas Pharma Global Development Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Nov 2016 → ongoing

Decision date (initial)

2024-04-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Astellas Pharma Global Development, Inc

External identifiers

EU CT number

2023-510298-33-00

EudraCT number

2016-001694-32

ClinicalTrials.gov

NCT02960022

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

The objective of the study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide (as assessed by the investigator) from their participation in an enzalutamide clinical study sponsored by Astellas or Medivation/Pfizer (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Conditions and MedDRA coding

Prostate Cancer

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. IRB/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.
2. Subject must currently be receiving enzalutamide for prostate 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.
3. Subjects are 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 approval (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.
4. Subject is able to swallow enzalutamide capsules and comply with study requirements.
5. Subject and his 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. Two acceptable forms of birth control include: ‡ Condom (barrier method of contraception), AND † In addition to a condom, 1 of the following acceptable forms of contraception is required: ● Established use of oral, injected or implanted hormonal methods of contraception ● Placement of an intrauterine device or intrauterine system ● Tubal ligation ● Vasectomy or other surgical castration prior to initial screening
6. Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration.

Exclusion criteria 4

1. Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from.
2. 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 (e.g., ADT). ● Investigational therapy other than enzalutamide.
3. Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide.
4. 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 in the opinion of the investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Not Applicable

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astellas Pharma Global Development Inc.

Sponsor organisation

Astellas Pharma Global Development Inc.

Address

2375 Waterview Drive

City

Northbrook

Postcode

60062-6111

Country

United States

Scientific contact point

Organisation

Astellas Pharma Global Development Inc.

Contact name

Head of Clinical Trial Unit Regulatory Affairs

Public contact point

Organisation

Astellas Pharma Global Development Inc.

Contact name

Head of Clinical Trial Unit Regulatory Affairs

Third parties 6

Locations

15 EU/EEA countries · 62 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 96 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications