A study to provide access to continued treatment for subjects with prostate cancer who are currently participating in an enzalutamide clinical study

• Register: EUCTR
• Last refreshed on: 14 November 2016
• Main ID: EUCTR2016-001694-32-ES
• Date of registration: 30/09/2016
• Prospective Registration: Yes
• Primary sponsor: Astellas Pharma Global Development, Inc.
• Public title: A study to provide access to continued treatment for subjects with prostate cancer who are currently participating in an enzalutamide clinical study
• Scientific title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study - Protocol 9785-CL-0123
• Date of first enrolment: 03/11/2016
• Target sample size: 272
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001694-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, Canada, Chile, Czech Republic, Denmark, France, Georgia, Germany, Moldova, Republic of, Netherlands, Russian Federation, South Africa, Spain, United Kingdom, United States

Contacts

• Name: Service Desk - Global Clinical Dev
• Affiliation: Astellas Pharma Europe B.V.

• Name: Service Desk - Global Clinical Dev
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion criteria:
Subject is eligible for the study if all of the following apply:
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 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
? Barrier methods of contraception: occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
? 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.
7. Subject agrees not to participate in another interventional study while on treatment.
Waivers to the inclusion criteria will NOT be allowed
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 68
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 204

Exclusion criteria:
Subject will be excluded from participation if any of the following apply:
1. Subject met any of the discontinuation criteria or progressed on the current enzalutamide clinical study in which they are enrolling from.
2. Subject requires treatment with or plans to use a strong CYP3A4 inducers or strong CYP2C8 inhibitors and using any narrow therapeutic index drugs that are metabolized by CYP3A4, CYP2C9) and CYP2C19 or investigational agents.
? 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
3. Subject is 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.
Waivers to the exclusion criteria will NOT be allowed.


Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

metastatic castration-resistant prostate cancer
MedDRA version: 19.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Trade Name: Xtandi
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: ENZALUTAMIDE
CAS Number: 915087-33-1
Current Sponsor code: MDV3100
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: na

Secondary Objective: NA

Primary end point(s): na

Main Objective: The objective of the study is to provide access to continued treatment for subjects who are currently participating in an enzalutamide clinical study for their prostate cancer and who are continuing to derive clinical benefit based on the assessment of the investigator.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: na

Secondary end point(s): na

Secondary ID(s)

9785-CL-0123

74,563

Source(s) of Monetary Support

Astellas Pharma Global Development, Inc.