E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic castration-resistant prostate cancer |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036909 |
E.1.2 | Term | Prostate cancer metastatic |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 Inc., a wholly owned subsidiary of Pfizer Inc. (Medivation/Pfizer) which as completed, at a minimum, the primary analysis or the study specified evaluation period. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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/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 ● 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 255 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Belgium |
Brazil |
Canada |
Chile |
China |
Czechia |
Denmark |
Finland |
France |
Germany |
Greece |
Hong Kong |
Israel |
Italy |
Korea, Republic of |
Malaysia |
Moldova, Republic of |
Netherlands |
New Zealand |
Poland |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Sweden |
Taiwan |
Thailand |
Turkey |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 8 |