Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer : An Open-label Phase 1 Study

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dc.contributor.authorMassard, Christophe
dc.contributor.authorPenttinen, Heidi M.
dc.contributor.authorVjaters, Egils
dc.contributor.authorBono, Petri
dc.contributor.authorLietuvietis, Vilnis
dc.contributor.authorTammela, Teuvo L.
dc.contributor.authorVuorela, Annamari
dc.contributor.authorNykänen, Pirjo
dc.contributor.authorPohjanjousi, Pasi
dc.contributor.authorSnapir, Amir
dc.contributor.authorFizazi, Karim
dc.date.accessioned2021-06-01T17:25:01Z
dc.date.available2021-06-01T17:25:01Z
dc.date.issued2016-05-01
dc.descriptionFunding Information: Funding/Support and role of the sponsor: Orion Corporation Orion Pharma in collaboration with Endo Pharmaceuticals Inc. supported the study. The sponsor was involved in the design and conduct the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval the manuscript. Medical writing assistance was funded by Orion Corporation. Publisher Copyright: © 2015 European Association of Urology. Published by Elsevier B.V. Copyright: Copyright 2018 Elsevier B.V., All rights reserved.
dc.description.abstractBackground ODM-201 is a novel second-generation androgen receptor inhibitor for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Objective To evaluate the pharmacokinetics of ODM-201 tablet products and preliminary long-term safety, tolerability, and antitumor activity of ODM-201 in chemotherapy-naive men with mCRPC. Design, setting, and participants Thirty patients were enrolled in this open-label phase 1 trial. Patients received a single 600-mg dose of ODM-201 in capsules with food and one 600-mg dose of ODM-201 tablet product (TabA or TabB) with food and in the fasted state in a random order. In the extension, patients received 600 mg twice daily ODM-201 taken with food in capsules. Outcome measurements and statistical analysis We analyzed the pharmacokinetics of ODM-201 tablet formulations. Safety and tolerability were assessed until disease progression or an intolerable adverse event (AE). Antitumor activity was assessed by prostate-specific antigen (PSA) levels and imaging. Results and limitations The capsule:TabA ratio of area under the concentration-time curve from time zero to the last sample at 48 h was 1.06 (90% confidence interval [CI], 0.91-1.24); the capsule:TabB ratio was 0.97 (90% CI, 0.82-1.14). At week 12, 25 of 30 patients (83%) had a PSA response (≥50% reduction from baseline). Median time to radiographic progression was 66 wk (95% CI, 41-79). Most common AEs were fatigue (n = 4 [13%]) and nausea (n = 4 [13%]). Conclusions The study showed that the tablet formulation of ODM-201 had similar pharmacokinetics compared with the capsule. Treatment with a 600-mg twice daily dose of ODM-201 provided anticancer activity and was well tolerated in men with chemotherapy-naive mCRPC. Patient summary The findings of this study showed that ODM-201 is well tolerated and provided antitumor activity in chemotherapy-naive patients with metastatic castration-resistant prostate cancer (mCRPC) and that the 300-mg tablet formulation can be used in further clinical studies. A phase 3 trial with ODM-201 600 mg twice daily in patients with non-mCRPC is ongoing.en
dc.description.statusPeer reviewed
dc.format.extent7
dc.format.extent995672
dc.identifier.citationMassard, C, Penttinen, H M, Vjaters, E, Bono, P, Lietuvietis, V, Tammela, T L, Vuorela, A, Nykänen, P, Pohjanjousi, P, Snapir, A & Fizazi, K 2016, 'Pharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer : An Open-label Phase 1 Study', European Urology, vol. 69, no. 5, pp. 834-840. https://doi.org/10.1016/j.eururo.2015.09.046
dc.identifier.doi10.1016/j.eururo.2015.09.046
dc.identifier.issn0302-2838
dc.identifier.urihttps://dspace.rsu.lv/jspui/handle/123456789/4620
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=84951827027&partnerID=8YFLogxK
dc.language.isoeng
dc.relation.ispartofEuropean Urology
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectAndrogen receptor inhibitor
dc.subjectCastration-resistant prostate cancer
dc.subjectODM-201
dc.subject3.2 Clinical medicine
dc.subject3.1 Basic medicine
dc.subject1.1. Scientific article indexed in Web of Science and/or Scopus database
dc.subjectUrology
dc.subjectSDG 3 - Good Health and Well-being
dc.titlePharmacokinetics, Antitumor Activity, and Safety of ODM-201 in Patients with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer : An Open-label Phase 1 Studyen
dc.type/dk/atira/pure/researchoutput/researchoutputtypes/contributiontojournal/article

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