A phase 2 study of momelotinib, a potent JAK1 and JAK2 inhibitor, in patients with polycythemia vera or essential thrombocythemia.
Identifieur interne : 001275 ( Main/Exploration ); précédent : 001274; suivant : 001276A phase 2 study of momelotinib, a potent JAK1 and JAK2 inhibitor, in patients with polycythemia vera or essential thrombocythemia.
Auteurs : Srdan Verstovsek [États-Unis] ; Stephane Courby [France] ; Martin Griesshammer [Allemagne] ; Ruben A. Mesa [États-Unis] ; Carrie Baker Brachmann [États-Unis] ; Jun Kawashima [États-Unis] ; Julia D. Maltzman [États-Unis] ; Lixin Shao [États-Unis] ; Yan Xin [États-Unis] ; Daniel Huang [États-Unis] ; Ashish Bajel [Australie]Source :
- Leukemia research [ 1873-5835 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Benzamides (effets indésirables), Benzamides (usage thérapeutique), Femelle, Humains, Inhibiteurs de protéines kinases (effets indésirables), Inhibiteurs de protéines kinases (usage thérapeutique), Janus kinase 1 (antagonistes et inhibiteurs), Kinase Janus-2 (antagonistes et inhibiteurs), Mâle, Polyglobulie primitive essentielle (traitement médicamenteux), Pyrimidines (effets indésirables), Pyrimidines (usage thérapeutique), Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Thrombocytémie essentielle (traitement médicamenteux).
- MESH :
- antagonistes et inhibiteurs : Janus kinase 1, Kinase Janus-2.
- effets indésirables : Benzamides, Inhibiteurs de protéines kinases, Pyrimidines.
- traitement médicamenteux : Polyglobulie primitive essentielle, Thrombocytémie essentielle.
- usage thérapeutique : Benzamides, Inhibiteurs de protéines kinases, Pyrimidines.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Mâle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Benzamides (adverse effects), Benzamides (therapeutic use), Female, Humans, Janus Kinase 1 (antagonists & inhibitors), Janus Kinase 2 (antagonists & inhibitors), Male, Middle Aged, Polycythemia Vera (drug therapy), Protein Kinase Inhibitors (adverse effects), Protein Kinase Inhibitors (therapeutic use), Pyrimidines (adverse effects), Pyrimidines (therapeutic use), Thrombocythemia, Essential (drug therapy), Treatment Outcome.
- MESH :
- chemical , adverse effects : Benzamides, Protein Kinase Inhibitors, Pyrimidines.
- chemical , antagonists & inhibitors : Janus Kinase 1, Janus Kinase 2.
- chemical , therapeutic use : Benzamides, Protein Kinase Inhibitors, Pyrimidines.
- drug therapy : Polycythemia Vera, Thrombocythemia, Essential.
- Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Momelotinib is a potent inhibitor of JAK1 and JAK2 that demonstrated efficacy in patients with primary and secondary myelofibrosis. This phase 2, open-label, randomized study evaluated the efficacy and safety of oral once-daily momelotinib (100mg and 200mg) for the treatment of polycythemia vera (PV) and essential thrombocythemia (ET). The primary endpoint for PV was overall response rate (ORR), defined as the proportion of patients with hematocrit <45%, white blood cell count <10×10(9)/L, platelet count ≤400×10(9)/L, and resolution of palpable splenomegaly, each lasting ≥4 weeks. The definition of ORR for ET excluded the hematocrit component. A total of 39 patients (28 PV, 11 ET) were enrolled, with 28 patients receiving ≥12 weeks of treatment. The study was terminated due to limited efficacy. Two patients (ORR 5.1%) met the primary efficacy endpoint (both PV 200mg). Predose plasma levels of momelotinib were stable over time. A total of 31 (79.5%) patients experienced momelotinib-related adverse events (AEs), the most frequent being headache (23.1%), dizziness (18.0%), somnolence (15.4%), nausea (15.4%), and fatigue (15.4%). Three patients experienced serious AEs (7.7%), with 1 considered related to momelotinib (dyspnea). Peripheral neuropathy occurred in 7 (17.9%) patients (4 PV, 3 ET).
DOI: 10.1016/j.leukres.2017.05.002
PubMed: 28622623
Affiliations:
- Allemagne, Australie, France, États-Unis
- Arizona, Auvergne-Rhône-Alpes, Californie, Rhône-Alpes, Texas
- Grenoble
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Le document en format XML
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Electronic address: kjnewber@mdanderson.org.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The University of Texas, MD Anderson Cancer Center, Houston, TX</wicri:regionArea><placeName><region type="state">Texas</region></placeName></affiliation></author><author><name sortKey="Courby, Stephane" sort="Courby, Stephane" uniqKey="Courby S" first="Stephane" last="Courby">Stephane Courby</name><affiliation wicri:level="3"><nlm:affiliation>Centre Hospitalier Universitaire de Grenoble, Grenoble, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Centre Hospitalier Universitaire de Grenoble, Grenoble</wicri:regionArea><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Grenoble</settlement></placeName></affiliation></author><author><name sortKey="Griesshammer, Martin" sort="Griesshammer, Martin" uniqKey="Griesshammer M" first="Martin" last="Griesshammer">Martin Griesshammer</name><affiliation wicri:level="1"><nlm:affiliation>Johannes Wesling Klinikum Minden, University of Bochum, Germany.</nlm:affiliation><country xml:lang="fr">Allemagne</country><wicri:regionArea>Johannes Wesling Klinikum Minden, University of Bochum</wicri:regionArea><wicri:noRegion>University of Bochum</wicri:noRegion><wicri:noRegion>University of Bochum</wicri:noRegion><wicri:noRegion>University of Bochum</wicri:noRegion></affiliation></author><author><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A" last="Mesa">Ruben A. Mesa</name><affiliation wicri:level="2"><nlm:affiliation>Mayo Clinic, Scottsdale, AZ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Mayo Clinic, Scottsdale, AZ</wicri:regionArea><placeName><region type="state">Arizona</region></placeName></affiliation></author><author><name sortKey="Brachmann, Carrie Baker" sort="Brachmann, Carrie Baker" uniqKey="Brachmann C" first="Carrie Baker" last="Brachmann">Carrie Baker Brachmann</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Inc., Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Inc., Foster City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Kawashima, Jun" sort="Kawashima, Jun" uniqKey="Kawashima J" first="Jun" last="Kawashima">Jun Kawashima</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Inc., Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Inc., Foster City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Maltzman, Julia D" sort="Maltzman, Julia D" uniqKey="Maltzman J" first="Julia D" last="Maltzman">Julia D. Maltzman</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Inc., Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Inc., Foster City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Shao, Lixin" sort="Shao, Lixin" uniqKey="Shao L" first="Lixin" last="Shao">Lixin Shao</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Inc., Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Inc., Foster City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Xin, Yan" sort="Xin, Yan" uniqKey="Xin Y" first="Yan" last="Xin">Yan Xin</name><affiliation wicri:level="2"><nlm:affiliation>Gilead Sciences, Inc., Foster City, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gilead Sciences, Inc., Foster City, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Huang, Daniel" sort="Huang, Daniel" uniqKey="Huang D" first="Daniel" last="Huang">Daniel Huang</name><affiliation wicri:level="2"><nlm:affiliation>The Oncology Institute of Hope and Innovation, Santa Ana, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>The Oncology Institute of Hope and Innovation, Santa Ana, CA</wicri:regionArea><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Bajel, Ashish" sort="Bajel, Ashish" uniqKey="Bajel A" first="Ashish" last="Bajel">Ashish Bajel</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Haematology and Bone Marrow Transplantation, Royal Melbourne Hospital, Victoria, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Department of Clinical Haematology and Bone Marrow Transplantation, Royal Melbourne Hospital, Victoria</wicri:regionArea><wicri:noRegion>Victoria</wicri:noRegion></affiliation></author></analytic><series><title level="j">Leukemia research</title><idno type="eISSN">1873-5835</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Benzamides (adverse effects)</term><term>Benzamides (therapeutic use)</term><term>Female</term><term>Humans</term><term>Janus Kinase 1 (antagonists & inhibitors)</term><term>Janus Kinase 2 (antagonists & inhibitors)</term><term>Male</term><term>Middle Aged</term><term>Polycythemia Vera (drug therapy)</term><term>Protein Kinase Inhibitors (adverse effects)</term><term>Protein Kinase Inhibitors (therapeutic use)</term><term>Pyrimidines (adverse effects)</term><term>Pyrimidines (therapeutic use)</term><term>Thrombocythemia, Essential (drug therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Benzamides (effets indésirables)</term><term>Benzamides (usage thérapeutique)</term><term>Femelle</term><term>Humains</term><term>Inhibiteurs de protéines kinases (effets indésirables)</term><term>Inhibiteurs de protéines kinases (usage thérapeutique)</term><term>Janus kinase 1 (antagonistes et inhibiteurs)</term><term>Kinase Janus-2 (antagonistes et inhibiteurs)</term><term>Mâle</term><term>Polyglobulie primitive essentielle (traitement médicamenteux)</term><term>Pyrimidines (effets indésirables)</term><term>Pyrimidines (usage thérapeutique)</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>Thrombocytémie essentielle (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Benzamides</term><term>Protein Kinase Inhibitors</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Janus Kinase 1</term><term>Janus Kinase 2</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Benzamides</term><term>Protein Kinase Inhibitors</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Janus kinase 1</term><term>Kinase Janus-2</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Polycythemia Vera</term><term>Thrombocythemia, Essential</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Benzamides</term><term>Inhibiteurs de protéines kinases</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Polyglobulie primitive essentielle</term><term>Thrombocytémie essentielle</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Benzamides</term><term>Inhibiteurs de protéines kinases</term><term>Pyrimidines</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Momelotinib is a potent inhibitor of JAK1 and JAK2 that demonstrated efficacy in patients with primary and secondary myelofibrosis. This phase 2, open-label, randomized study evaluated the efficacy and safety of oral once-daily momelotinib (100mg and 200mg) for the treatment of polycythemia vera (PV) and essential thrombocythemia (ET). The primary endpoint for PV was overall response rate (ORR), defined as the proportion of patients with hematocrit <45%, white blood cell count <10×10(9)/L, platelet count ≤400×10(9)/L, and resolution of palpable splenomegaly, each lasting ≥4 weeks. The definition of ORR for ET excluded the hematocrit component. A total of 39 patients (28 PV, 11 ET) were enrolled, with 28 patients receiving ≥12 weeks of treatment. The study was terminated due to limited efficacy. Two patients (ORR 5.1%) met the primary efficacy endpoint (both PV 200mg). Predose plasma levels of momelotinib were stable over time. A total of 31 (79.5%) patients experienced momelotinib-related adverse events (AEs), the most frequent being headache (23.1%), dizziness (18.0%), somnolence (15.4%), nausea (15.4%), and fatigue (15.4%). Three patients experienced serious AEs (7.7%), with 1 considered related to momelotinib (dyspnea). Peripheral neuropathy occurred in 7 (17.9%) patients (4 PV, 3 ET).</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>France</li><li>États-Unis</li></country><region><li>Arizona</li><li>Auvergne-Rhône-Alpes</li><li>Californie</li><li>Rhône-Alpes</li><li>Texas</li></region><settlement><li>Grenoble</li></settlement></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Verstovsek, Srdan" sort="Verstovsek, Srdan" uniqKey="Verstovsek S" first="Srdan" last="Verstovsek">Srdan Verstovsek</name></region><name sortKey="Brachmann, Carrie Baker" sort="Brachmann, Carrie Baker" uniqKey="Brachmann C" first="Carrie Baker" last="Brachmann">Carrie Baker Brachmann</name><name sortKey="Huang, Daniel" sort="Huang, Daniel" uniqKey="Huang D" first="Daniel" last="Huang">Daniel Huang</name><name sortKey="Kawashima, Jun" sort="Kawashima, Jun" uniqKey="Kawashima J" first="Jun" last="Kawashima">Jun Kawashima</name><name sortKey="Maltzman, Julia D" sort="Maltzman, Julia D" uniqKey="Maltzman J" first="Julia D" last="Maltzman">Julia D. Maltzman</name><name sortKey="Mesa, Ruben A" sort="Mesa, Ruben A" uniqKey="Mesa R" first="Ruben A" last="Mesa">Ruben A. Mesa</name><name sortKey="Shao, Lixin" sort="Shao, Lixin" uniqKey="Shao L" first="Lixin" last="Shao">Lixin Shao</name><name sortKey="Xin, Yan" sort="Xin, Yan" uniqKey="Xin Y" first="Yan" last="Xin">Yan Xin</name></country><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Courby, Stephane" sort="Courby, Stephane" uniqKey="Courby S" first="Stephane" last="Courby">Stephane Courby</name></region></country><country name="Allemagne"><noRegion><name sortKey="Griesshammer, Martin" sort="Griesshammer, Martin" uniqKey="Griesshammer M" first="Martin" last="Griesshammer">Martin Griesshammer</name></noRegion></country><country name="Australie"><noRegion><name sortKey="Bajel, Ashish" sort="Bajel, Ashish" uniqKey="Bajel A" first="Ashish" last="Bajel">Ashish Bajel</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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