Trial record 1 of 1 for:
9785-CL-0123
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02960022 |
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Recruitment Status :
Recruiting
First Posted : November 9, 2016
Last Update Posted : December 24, 2020
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Sponsor:
Astellas Pharma Global Development, Inc.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day
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Drug: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
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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
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Drug: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day.
Other Names:
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 |
Primary Outcome Measures :
- Number of participants with adverse events [ Time Frame: Until End of Study (Up to 44 Months) ]
Information from the National Library of Medicine
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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.
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960022
Contacts
| Contact: Astellas Pharma Global Development | 800-888-7704 | astellas.registration@astellas.com |
Locations
Show 122 study locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Pfizer
Investigators
| Study Director: | Associate Medical Director | Astellas Pharma Global Development, Inc. |
| Responsible Party: | Astellas Pharma Global Development, Inc. |
| ClinicalTrials.gov Identifier: | NCT02960022 |
| Other Study ID Numbers: |
9785-CL-0123 2016-001694-32 ( EudraCT Number ) |
| First Posted: | November 9, 2016 Key Record Dates |
| Last Update Posted: | December 24, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
| Time Frame: | Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data. |
| Access Criteria: | Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement. |
| URL: | https://www.clinicalstudydatarequest.com/ |
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
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prostate cancer prednisone MDV3100 |
enzalutamide Xtandi abiraterone acetate |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms 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 |