A Study to Evaluate Enzalutamide After Abiraterone in Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT02116582
Last Updated: 2024-12-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
215 participants
INTERVENTIONAL
2014-05-23
2017-09-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Enzalutamide
Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
Enzalutamide
Participants received 160 mg of enzalutamide (soft capsules) orally once daily.
Interventions
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Enzalutamide
Participants received 160 mg of enzalutamide (soft capsules) orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has metastatic disease documented by bone scan or by soft tissue disease observed by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) at screening, or within ≤30 days prior to Day 1.
* In the setting of castrate levels of testosterone ≤1.7 nmol/L (or ≤50 ng/dL), subject has progressive disease at study entry defined as PSA rise determined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each assessment. The PSA value at the screening visit should be ≥ 2 ng/mL WITH or WITHOUT:
* Soft tissue disease progression defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) at screening, or within ≤30 days prior to Day 1. Measurable disease is not required for entry. Lymph nodes ≥ 2 cm are considered measurable disease (Prostate Cancer Clinical Trials Working Group (PCWG2)).
* Bone disease progression defined by at least 2 new lesions on bone scan at screening, or within ≤30 days prior to Day 1.
* Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate within its approved label indication and has discontinued use at least 4 weeks prior to start of study drug at Day 1.
* If the subject has received previous treatment with chemotherapy for prostate cancer, this must be limited to no more than one prior line of docetaxel, and must have been used prior to abiraterone acetate therapy.
* Subject receives and will continue to receive ongoing androgen deprivation with Luteinizing-hormone-releasing hormone (LHRH) analogue therapy throughout the course of the study or has had a bilateral orchiectomy.
* Subject is asymptomatic or mildly symptomatic from prostate cancer:
* The score on Brief Pain Inventory - Short Form (BPI-SF) Question #3 must be \< 4.
* No use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to screening.
Exclusion Criteria
* Subject has prior use of cabazitaxel.
* Subject has prior use of enzalutamide.
* Subject has received ANY anti-neoplastic therapy (including antiandrogens and chemotherapy) following abiraterone acetate discontinuation and prior to start of study drug at Day 1.
* Subject has a known or suspected hypersensitivity to enzalutamide, or any components of the formulation used.
* Subject has known or suspected brain metastases or active leptomeningeal disease.
* Subject has history of seizure or any condition that may predispose to seizure (e.g., prior stroke or significant brain trauma).
18 Years
MALE
No
Sponsors
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Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
INDUSTRY
Astellas Pharma Europe B.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Europe B.V.
Locations
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Site BE32001
Brussels, Flemish Brabant, Belgium
Site BE32004
Ghent, , Belgium
Site BE32007
Hasselt, , Belgium
Site BE32003
Kortrijk, , Belgium
Site BE32002
Liège, , Belgium
Site FR33015
Angers, , France
Site FR33009
Caen, , France
Site FR33010
Créteil, , France
Site FR33014
Le Mans, , France
Site FR33013
Lyon, , France
Site FR33003
Marseille, , France
Site FR33008
Nantes Saint Herblain Cedex, , France
Site FR33002
Nîmes, , France
Site FR33011
Paris, , France
Site FR33001
Paris, , France
Site FR33007
Rennes, , France
Site FR33005
Suresnes, , France
Site FR33012
Villejiuf, , France
Site DE49005
Nürtingen, Baden-Wurttemberg, Germany
Site DE49017
Duisburg, North Rhine-Westphalia, Germany
Site DE49015
Bergisch Gladbach, Northwest, Germany
Site DE49014
Berlin, , Germany
Site DE49003
Berlin, , Germany
Site DE49009
Bonn, , Germany
Site DE49010
Dresden, , Germany
Site DE49016
Düsseldorf, , Germany
Site DE49004
Göttingen, , Germany
Site DE49001
Hamburg, , Germany
Site DE49008
Hamburg, , Germany
Site DE49007
Hanover, , Germany
Site DE49002
Heidelberg, , Germany
Site DE49012
Münster, , Germany
Site DE49006
Tübingen, , Germany
Site ES34004
Santiago de Compostela, A Coruna, Spain
Site ES34009
Badalona, , Spain
Site ES34011
Barcelona, , Spain
Site ES34006
Barcelona, , Spain
Site ES34008
Barcelona, , Spain
Site ES34001
Madrid, , Spain
Site ES34003
Madrid, , Spain
Site ES34002
Madrid, , Spain
Site ES34010
Madrid, , Spain
Site GB44001
Sutton, Surrey, United Kingdom
Site GB44004
Birmingham, , United Kingdom
Site GB44009
Brighton, , United Kingdom
Site GB44002
Glasgow, , United Kingdom
Site GB44007
London, , United Kingdom
Site GB44003
Northwood, Middlesex, , United Kingdom
Site GB44010
Plymouth, , United Kingdom
Site GB44006
Withington, , United Kingdom
Countries
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References
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de Bono JS, Chowdhury S, Feyerabend S, Elliott T, Grande E, Melhem-Bertrandt A, Baron B, Hirmand M, Werbrouck P, Fizazi K. Antitumour Activity and Safety of Enzalutamide in Patients with Metastatic Castration-resistant Prostate Cancer Previously Treated with Abiraterone Acetate Plus Prednisone for >/=24 weeks in Europe. Eur Urol. 2018 Jul;74(1):37-45. doi: 10.1016/j.eururo.2017.07.035. Epub 2017 Aug 23.
Related Links
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Link to results on the Astellas Clinical Study Results website
Other Identifiers
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2013-002271-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9785-CL-0410
Identifier Type: -
Identifier Source: org_study_id