Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.
Identifieur interne : 000125 ( France/Analysis ); précédent : 000124; suivant : 000126Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial.
Auteurs : Karim Fizazi [France] ; Christophe Massard [France] ; Petri Bono [Finlande] ; Robert Jones [Royaume-Uni] ; Vesa Kataja [Finlande] ; Nicholas James [Royaume-Uni] ; Jorge A. Garcia [États-Unis] ; Andrew Protheroe [Royaume-Uni] ; Teuvo L. Tammela [Finlande] ; Tony Elliott [Royaume-Uni] ; Leena Mattila [Finlande] ; John Aspegren [Finlande] ; Annamari Vuorela [Finlande] ; Peter Langmuir [États-Unis] ; Mika Mustonen [Finlande]Source :
- The Lancet. Oncology [ 1474-5488 ] ; 2014.
Descripteurs français
- KwdFr :
- Administration par voie orale, Adulte d'âge moyen, Antagonistes du récepteur des androgènes (pharmacologie), Antigène spécifique de la prostate (sang), Calendrier d'administration des médicaments, Dose maximale tolérée, Estimation de Kaplan-Meier, Humains, Intervalles de confiance, Invasion tumorale (anatomopathologie), Mâle, Métastase tumorale, Pronostic, Pyrazoles (pharmacologie), Relation dose-effet des médicaments, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Survie sans rechute, Sécurité des patients, Sélection de patients, Taux de survie, Tumeurs prostatiques résistantes à la castration (anatomopathologie), Tumeurs prostatiques résistantes à la castration (mortalité), Tumeurs prostatiques résistantes à la castration (traitement médicamenteux).
- MESH :
- anatomopathologie : Invasion tumorale, Tumeurs prostatiques résistantes à la castration.
- mortalité : Tumeurs prostatiques résistantes à la castration.
- pharmacologie : Antagonistes du récepteur des androgènes, Pyrazoles.
- sang : Antigène spécifique de la prostate.
- traitement médicamenteux : Tumeurs prostatiques résistantes à la castration.
- Administration par voie orale, Adulte d'âge moyen, Calendrier d'administration des médicaments, Dose maximale tolérée, Estimation de Kaplan-Meier, Humains, Intervalles de confiance, Mâle, Métastase tumorale, Pronostic, Relation dose-effet des médicaments, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Survie sans rechute, Sécurité des patients, Sélection de patients, Taux de survie.
English descriptors
- KwdEn :
- Administration, Oral, Aged, Androgen Receptor Antagonists (pharmacology), Confidence Intervals, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Invasiveness (pathology), Neoplasm Metastasis, Neoplasm Staging, Patient Safety, Patient Selection, Prognosis, Prostate-Specific Antigen (blood), Prostatic Neoplasms, Castration-Resistant (drug therapy), Prostatic Neoplasms, Castration-Resistant (mortality), Prostatic Neoplasms, Castration-Resistant (pathology), Pyrazoles (pharmacology), Survival Rate, Treatment Outcome.
- MESH :
- chemical , blood : Prostate-Specific Antigen.
- chemical , pharmacology : Androgen Receptor Antagonists, Pyrazoles.
- drug therapy : Prostatic Neoplasms, Castration-Resistant.
- mortality : Prostatic Neoplasms, Castration-Resistant.
- pathology : Neoplasm Invasiveness, Prostatic Neoplasms, Castration-Resistant.
- Administration, Oral, Aged, Confidence Intervals, Disease-Free Survival, Dose-Response Relationship, Drug, Drug Administration Schedule, Humans, Kaplan-Meier Estimate, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Patient Safety, Patient Selection, Prognosis, Survival Rate, Treatment Outcome.
Abstract
ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.
DOI: 10.1016/S1470-2045(14)70240-2
PubMed: 24974051
Affiliations:
- Finlande, France, Royaume-Uni, États-Unis
- Angleterre, Grand Manchester, Midlands de l'Ouest, Ohio, Oxfordshire
- Birmingham, Manchester, Oxford
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pubmed:24974051Le document en format XML
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Electronic address: fizazi@igr.fr.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut Gustave Roussy, University of Paris Sud, Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Massard, Christophe" sort="Massard, Christophe" uniqKey="Massard C" first="Christophe" last="Massard">Christophe Massard</name><affiliation wicri:level="1"><nlm:affiliation>Institut Gustave Roussy, University of Paris Sud, Villejuif, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut Gustave Roussy, University of Paris Sud, Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Bono, Petri" sort="Bono, Petri" uniqKey="Bono P" first="Petri" last="Bono">Petri Bono</name><affiliation wicri:level="1"><nlm:affiliation>Cancer Center, Helsinki University Central Hospital, Helsinki, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Cancer Center, Helsinki University Central Hospital, Helsinki</wicri:regionArea><wicri:noRegion>Helsinki</wicri:noRegion></affiliation></author><author><name sortKey="Jones, Robert" sort="Jones, Robert" uniqKey="Jones R" first="Robert" last="Jones">Robert Jones</name><affiliation wicri:level="1"><nlm:affiliation>Velindre Cancer Centre, Cardiff, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Velindre Cancer Centre, Cardiff</wicri:regionArea><wicri:noRegion>Cardiff</wicri:noRegion></affiliation></author><author><name sortKey="Kataja, Vesa" sort="Kataja, Vesa" uniqKey="Kataja V" first="Vesa" last="Kataja">Vesa Kataja</name><affiliation wicri:level="1"><nlm:affiliation>Kuopio University Hospital, Kuopio, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Kuopio University Hospital, Kuopio</wicri:regionArea><wicri:noRegion>Kuopio</wicri:noRegion></affiliation></author><author><name sortKey="James, Nicholas" sort="James, Nicholas" uniqKey="James N" first="Nicholas" last="James">Nicholas James</name><affiliation wicri:level="3"><nlm:affiliation>Queen Elizabeth Hospital, Birmingham, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Queen Elizabeth Hospital, Birmingham</wicri:regionArea><placeName><settlement type="city">Birmingham</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Midlands de l'Ouest</region></placeName></affiliation></author><author><name sortKey="Garcia, Jorge A" sort="Garcia, Jorge A" uniqKey="Garcia J" first="Jorge A" last="Garcia">Jorge A. Garcia</name><affiliation wicri:level="2"><nlm:affiliation>Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio</wicri:regionArea><placeName><region type="state">Ohio</region></placeName></affiliation></author><author><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name><affiliation wicri:level="3"><nlm:affiliation>Churchill Hospital, Oxford, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Churchill Hospital, Oxford</wicri:regionArea><placeName><settlement type="city">Oxford</settlement><region type="country">Angleterre</region><region type="comté" nuts="2">Oxfordshire</region></placeName></affiliation></author><author><name sortKey="Tammela, Teuvo L" sort="Tammela, Teuvo L" uniqKey="Tammela T" first="Teuvo L" last="Tammela">Teuvo L. Tammela</name><affiliation wicri:level="1"><nlm:affiliation>Tampere University Hospital, Tampere, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Tampere University Hospital, Tampere</wicri:regionArea><wicri:noRegion>Tampere</wicri:noRegion></affiliation></author><author><name sortKey="Elliott, Tony" sort="Elliott, Tony" uniqKey="Elliott T" first="Tony" last="Elliott">Tony Elliott</name><affiliation wicri:level="3"><nlm:affiliation>Christie Hospital NHS, Manchester, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Christie Hospital NHS, Manchester</wicri:regionArea><placeName><settlement type="city">Manchester</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Manchester</region></placeName></affiliation></author><author><name sortKey="Mattila, Leena" sort="Mattila, Leena" uniqKey="Mattila L" first="Leena" last="Mattila">Leena Mattila</name><affiliation wicri:level="1"><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Orion Corporation Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author><author><name sortKey="Aspegren, John" sort="Aspegren, John" uniqKey="Aspegren J" first="John" last="Aspegren">John Aspegren</name><affiliation wicri:level="1"><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Orion Corporation Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author><author><name sortKey="Vuorela, Annamari" sort="Vuorela, Annamari" uniqKey="Vuorela A" first="Annamari" last="Vuorela">Annamari Vuorela</name><affiliation wicri:level="1"><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Orion Corporation Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author><author><name sortKey="Langmuir, Peter" sort="Langmuir, Peter" uniqKey="Langmuir P" first="Peter" last="Langmuir">Peter Langmuir</name><affiliation wicri:level="1"><nlm:affiliation>Endo Pharmaceuticals, Malvern, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Endo Pharmaceuticals, Malvern</wicri:regionArea><wicri:noRegion>Malvern</wicri:noRegion></affiliation></author><author><name sortKey="Mustonen, Mika" sort="Mustonen, Mika" uniqKey="Mustonen M" first="Mika" last="Mustonen">Mika Mustonen</name><affiliation wicri:level="1"><nlm:affiliation>Orion Corporation Orion Pharma, Espoo, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Orion Corporation Orion Pharma, Espoo</wicri:regionArea><wicri:noRegion>Espoo</wicri:noRegion></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Oral</term><term>Aged</term><term>Androgen Receptor Antagonists (pharmacology)</term><term>Confidence Intervals</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Maximum Tolerated Dose</term><term>Middle Aged</term><term>Neoplasm Invasiveness (pathology)</term><term>Neoplasm Metastasis</term><term>Neoplasm Staging</term><term>Patient Safety</term><term>Patient Selection</term><term>Prognosis</term><term>Prostate-Specific Antigen (blood)</term><term>Prostatic Neoplasms, Castration-Resistant (drug therapy)</term><term>Prostatic Neoplasms, Castration-Resistant (mortality)</term><term>Prostatic Neoplasms, Castration-Resistant (pathology)</term><term>Pyrazoles (pharmacology)</term><term>Survival Rate</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Administration par voie orale</term><term>Adulte d'âge moyen</term><term>Antagonistes du récepteur des androgènes (pharmacologie)</term><term>Antigène spécifique de la prostate (sang)</term><term>Calendrier d'administration des médicaments</term><term>Dose maximale tolérée</term><term>Estimation de Kaplan-Meier</term><term>Humains</term><term>Intervalles de confiance</term><term>Invasion tumorale (anatomopathologie)</term><term>Mâle</term><term>Métastase tumorale</term><term>Pronostic</term><term>Pyrazoles (pharmacologie)</term><term>Relation dose-effet des médicaments</term><term>Résultat thérapeutique</term><term>Stade de la tumeur</term><term>Sujet âgé</term><term>Survie sans rechute</term><term>Sécurité des patients</term><term>Sélection de patients</term><term>Taux de survie</term><term>Tumeurs prostatiques résistantes à la castration (anatomopathologie)</term><term>Tumeurs prostatiques résistantes à la castration (mortalité)</term><term>Tumeurs prostatiques résistantes à la castration (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Prostate-Specific Antigen</term></keywords><keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Androgen Receptor Antagonists</term><term>Pyrazoles</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Invasion tumorale</term><term>Tumeurs prostatiques résistantes à la castration</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Tumeurs prostatiques résistantes à la castration</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Neoplasm Invasiveness</term><term>Prostatic Neoplasms, Castration-Resistant</term></keywords><keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Antagonistes du récepteur des androgènes</term><term>Pyrazoles</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Antigène spécifique de la prostate</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs prostatiques résistantes à la castration</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Oral</term><term>Aged</term><term>Confidence Intervals</term><term>Disease-Free Survival</term><term>Dose-Response Relationship, Drug</term><term>Drug Administration Schedule</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Maximum Tolerated Dose</term><term>Middle Aged</term><term>Neoplasm Metastasis</term><term>Neoplasm Staging</term><term>Patient Safety</term><term>Patient Selection</term><term>Prognosis</term><term>Survival Rate</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Administration par voie orale</term><term>Adulte d'âge moyen</term><term>Calendrier d'administration des médicaments</term><term>Dose maximale tolérée</term><term>Estimation de Kaplan-Meier</term><term>Humains</term><term>Intervalles de confiance</term><term>Mâle</term><term>Métastase tumorale</term><term>Pronostic</term><term>Relation dose-effet des médicaments</term><term>Résultat thérapeutique</term><term>Stade de la tumeur</term><term>Sujet âgé</term><term>Survie sans rechute</term><term>Sécurité des patients</term><term>Sélection de patients</term><term>Taux de survie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">ODM-201 is a novel androgen receptor (AR) inhibitor designed to block the growth of prostate cancer cells through high-affinity binding to the AR and inhibition of AR nuclear translocation. This trial assessed ODM-201's safety, pharmacokinetics, and activity in men with metastatic castration-resistant prostate cancer.</div></front></TEI><affiliations><list><country><li>Finlande</li><li>France</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Grand Manchester</li><li>Midlands de l'Ouest</li><li>Ohio</li><li>Oxfordshire</li></region><settlement><li>Birmingham</li><li>Manchester</li><li>Oxford</li></settlement></list><tree><country name="France"><noRegion><name sortKey="Fizazi, Karim" sort="Fizazi, Karim" uniqKey="Fizazi K" first="Karim" last="Fizazi">Karim Fizazi</name></noRegion><name sortKey="Massard, Christophe" sort="Massard, Christophe" uniqKey="Massard C" first="Christophe" last="Massard">Christophe Massard</name></country><country name="Finlande"><noRegion><name sortKey="Bono, Petri" sort="Bono, Petri" uniqKey="Bono P" first="Petri" last="Bono">Petri Bono</name></noRegion><name sortKey="Aspegren, John" sort="Aspegren, John" uniqKey="Aspegren J" first="John" last="Aspegren">John Aspegren</name><name sortKey="Kataja, Vesa" sort="Kataja, Vesa" uniqKey="Kataja V" first="Vesa" last="Kataja">Vesa Kataja</name><name sortKey="Mattila, Leena" sort="Mattila, Leena" uniqKey="Mattila L" first="Leena" last="Mattila">Leena Mattila</name><name sortKey="Mustonen, Mika" sort="Mustonen, Mika" uniqKey="Mustonen M" first="Mika" last="Mustonen">Mika Mustonen</name><name sortKey="Tammela, Teuvo L" sort="Tammela, Teuvo L" uniqKey="Tammela T" first="Teuvo L" last="Tammela">Teuvo L. Tammela</name><name sortKey="Vuorela, Annamari" sort="Vuorela, Annamari" uniqKey="Vuorela A" first="Annamari" last="Vuorela">Annamari Vuorela</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Jones, Robert" sort="Jones, Robert" uniqKey="Jones R" first="Robert" last="Jones">Robert Jones</name></noRegion><name sortKey="Elliott, Tony" sort="Elliott, Tony" uniqKey="Elliott T" first="Tony" last="Elliott">Tony Elliott</name><name sortKey="James, Nicholas" sort="James, Nicholas" uniqKey="James N" first="Nicholas" last="James">Nicholas James</name><name sortKey="Protheroe, Andrew" sort="Protheroe, Andrew" uniqKey="Protheroe A" first="Andrew" last="Protheroe">Andrew Protheroe</name></country><country name="États-Unis"><region name="Ohio"><name sortKey="Garcia, Jorge A" sort="Garcia, Jorge A" uniqKey="Garcia J" first="Jorge A" last="Garcia">Jorge A. Garcia</name></region><name sortKey="Langmuir, Peter" sort="Langmuir, Peter" uniqKey="Langmuir P" first="Peter" last="Langmuir">Peter Langmuir</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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