A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia
Identifieur interne : 003C43 ( Main/Exploration ); précédent : 003C42; suivant : 003C44A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia
Auteurs : J F Seymour [Australie] ; D W Kim [Corée du Sud] ; E. Rubin [États-Unis] ; A. Haregewoin [États-Unis] ; J. Clark [États-Unis] ; P. Watson [États-Unis] ; T. Hughes [Australie] ; I. Dufva [Danemark] ; J L Jimenez [Espagne] ; F-X Mahon [France] ; P. Rousselot [France] ; J. Cortes [États-Unis] ; G. Martinelli [Italie] ; C. Papayannidis [Italie] ; A. Nagler [Israël] ; F J Giles [États-Unis]Source :
- Blood Cancer Journal [ 2044-5385 ] ; 2014.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Chromosome Philadelphie, Femelle, Humains, Inhibiteurs de protéines kinases (administration et posologie), Leucémie myéloïde chronique BCR-ABL positive (génétique), Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux), Leucémie-lymphome lymphoblastique à précurseurs B et T (génétique), Leucémie-lymphome lymphoblastique à précurseurs B et T (traitement médicamenteux), Mutation faux-sens, Mâle, Pipérazines (administration et posologie), Protéines de fusion bcr-abl (génétique), Substitution d'acide aminé, Sujet âgé.
- MESH :
- administration et posologie : Inhibiteurs de protéines kinases, Pipérazines.
- génétique : Leucémie myéloïde chronique BCR-ABL positive, Leucémie-lymphome lymphoblastique à précurseurs B et T, Protéines de fusion bcr-abl.
- traitement médicamenteux : Leucémie myéloïde chronique BCR-ABL positive, Leucémie-lymphome lymphoblastique à précurseurs B et T.
- Adulte, Adulte d'âge moyen, Chromosome Philadelphie, Femelle, Humains, Mutation faux-sens, Mâle, Substitution d'acide aminé, Sujet âgé.
English descriptors
- KwdEn :
- Adult, Aged, Amino Acid Substitution, Female, Fusion Proteins, bcr-abl (genetics), Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy), Leukemia, Myelogenous, Chronic, BCR-ABL Positive (genetics), Male, Middle Aged, Mutation, Missense, Philadelphia Chromosome, Piperazines (administration & dosage), Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy), Precursor Cell Lymphoblastic Leukemia-Lymphoma (genetics), Protein Kinase Inhibitors (administration & dosage).
- MESH :
- chemical , administration & dosage : Piperazines, Protein Kinase Inhibitors.
- chemical , genetics : Fusion Proteins, bcr-abl.
- drug therapy : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma.
- genetics : Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Precursor Cell Lymphoblastic Leukemia-Lymphoma.
- Adult, Aged, Amino Acid Substitution, Female, Humans, Male, Middle Aged, Mutation, Missense, Philadelphia Chromosome.
Abstract
Aurora kinase overexpression has been observed in patients with hematologic malignancies. MK-0457, a pan-aurora kinase inhibitor that also inhibits the ABL T315I mutant, was evaluated to treat patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL) with the T315I mutation. Adults with Ph+ chronic phase (CP)-, accelerated phase (AP)- or blast phase (BP)-CML, or ALL and documented BCR-ABL T315I mutation were treated with a 5-day continuous infusion of MK-0457 administered every 14 days at 40 mg/m2/h, 32 mg/m2/h or 24 mg/m2/h. Fifty-two patients (CP,
Url:
DOI: 10.1038/bcj.2014.60
PubMed: 25127392
PubMed Central: 4219463
Affiliations:
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Nagler</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Chaim Sheba Medical Center</institution>, Tel Hashomer,<country>Israel</country></nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Giles, F J" sort="Giles, F J" uniqKey="Giles F" first="F J" last="Giles">F J Giles</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Northwestern Medicine Developmental Therapeutics Institute</institution>, Chicago, IL,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25127392</idno><idno type="pmc">4219463</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4219463</idno><idno type="RBID">PMC:4219463</idno><idno type="doi">10.1038/bcj.2014.60</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000076</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000076</idno><idno type="wicri:Area/Pmc/Curation">000076</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000076</idno><idno type="wicri:Area/Pmc/Checkpoint">001768</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001768</idno><idno type="wicri:source">PubMed</idno><idno type="wicri:Area/PubMed/Corpus">003564</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003564</idno><idno type="wicri:Area/PubMed/Curation">003451</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">003451</idno><idno type="wicri:Area/PubMed/Checkpoint">003451</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">003451</idno><idno type="wicri:Area/Ncbi/Merge">001D18</idno><idno type="wicri:Area/Ncbi/Curation">001D18</idno><idno type="wicri:Area/Ncbi/Checkpoint">001D18</idno><idno type="wicri:Area/Main/Merge">003C94</idno><idno type="wicri:Area/Main/Curation">003C43</idno><idno type="wicri:Area/Main/Exploration">003C43</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A phase 2 study of MK-0457 in patients with BCR-ABL T315I mutant chronic myelogenous leukemia and philadelphia chromosome-positive acute lymphoblastic leukemia</title><author><name sortKey="Seymour, J F" sort="Seymour, J F" uniqKey="Seymour J" first="J F" last="Seymour">J F Seymour</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Haematology Service Division of Cancer Medicine, Department of Haematology, Peter MacCallum Cancer Centre, East Melbourne, University of Melbourne</institution>, Parkville,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kim, D W" sort="Kim, D W" uniqKey="Kim D" first="D W" last="Kim">D W Kim</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>St. Mary's Hospital</institution>, Seoul,<country>South Korea</country></nlm:aff><country xml:lang="fr">Corée du Sud</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rubin, E" sort="Rubin, E" uniqKey="Rubin E" first="E" last="Rubin">E. Rubin</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Merck & Co., Inc</institution>, Whitehouse Station, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Haregewoin, A" sort="Haregewoin, A" uniqKey="Haregewoin A" first="A" last="Haregewoin">A. Haregewoin</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Merck & Co., Inc</institution>, Whitehouse Station, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Clark, J" sort="Clark, J" uniqKey="Clark J" first="J" last="Clark">J. Clark</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Merck & Co., Inc</institution>, Whitehouse Station, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Watson, P" sort="Watson, P" uniqKey="Watson P" first="P" last="Watson">P. Watson</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Merck & Co., Inc</institution>, Whitehouse Station, NJ,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hughes, T" sort="Hughes, T" uniqKey="Hughes T" first="T" last="Hughes">T. Hughes</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Haematology, SA Pathology</institution>, Adelaide,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Dufva, I" sort="Dufva, I" uniqKey="Dufva I" first="I" last="Dufva">I. Dufva</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>Herlev University Hospital</institution>, Herlev,<country>Denmark</country></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Jimenez, J L" sort="Jimenez, J L" uniqKey="Jimenez J" first="J L" last="Jimenez">J L Jimenez</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Hospital Universitario Ramon y Cajal</institution>, Madrid,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Mahon, F X" sort="Mahon, F X" uniqKey="Mahon F" first="F-X" last="Mahon">F-X Mahon</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Hôpital Pellegrin, CHU de Bordeaux</institution>, Bordeaux,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Rousselot, P" sort="Rousselot, P" uniqKey="Rousselot P" first="P" last="Rousselot">P. Rousselot</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Hopital de Versailles, Université Versailles Saint Quentin en</institution>, Yvelines,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Cortes, J" sort="Cortes, J" uniqKey="Cortes J" first="J" last="Cortes">J. Cortes</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>MD Anderson Cancer Center</institution>, Houston, TX,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Martinelli, G" sort="Martinelli, G" uniqKey="Martinelli G" first="G" last="Martinelli">G. Martinelli</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>University of Bologna</institution>, Bologna,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Papayannidis, C" sort="Papayannidis, C" uniqKey="Papayannidis C" first="C" last="Papayannidis">C. Papayannidis</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>University of Bologna</institution>, Bologna,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Nagler, A" sort="Nagler, A" uniqKey="Nagler A" first="A" last="Nagler">A. Nagler</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Chaim Sheba Medical Center</institution>, Tel Hashomer,<country>Israel</country></nlm:aff><country xml:lang="fr">Israël</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Giles, F J" sort="Giles, F J" uniqKey="Giles F" first="F J" last="Giles">F J Giles</name><affiliation wicri:level="1"><nlm:aff id="aff12"><institution>Northwestern Medicine Developmental Therapeutics Institute</institution>, Chicago, IL,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Blood Cancer Journal</title><idno type="eISSN">2044-5385</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Amino Acid Substitution</term><term>Female</term><term>Fusion Proteins, bcr-abl (genetics)</term><term>Humans</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (drug therapy)</term><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive (genetics)</term><term>Male</term><term>Middle Aged</term><term>Mutation, Missense</term><term>Philadelphia Chromosome</term><term>Piperazines (administration & dosage)</term><term>Precursor Cell Lymphoblastic Leukemia-Lymphoma (drug therapy)</term><term>Precursor Cell Lymphoblastic Leukemia-Lymphoma (genetics)</term><term>Protein Kinase Inhibitors (administration & dosage)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Chromosome Philadelphie</term><term>Femelle</term><term>Humains</term><term>Inhibiteurs de protéines kinases (administration et posologie)</term><term>Leucémie myéloïde chronique BCR-ABL positive (génétique)</term><term>Leucémie myéloïde chronique BCR-ABL positive (traitement médicamenteux)</term><term>Leucémie-lymphome lymphoblastique à précurseurs B et T (génétique)</term><term>Leucémie-lymphome lymphoblastique à précurseurs B et T (traitement médicamenteux)</term><term>Mutation faux-sens</term><term>Mâle</term><term>Pipérazines (administration et posologie)</term><term>Protéines de fusion bcr-abl (génétique)</term><term>Substitution d'acide aminé</term><term>Sujet âgé</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Piperazines</term><term>Protein Kinase Inhibitors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="genetics" xml:lang="en"><term>Fusion Proteins, bcr-abl</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Inhibiteurs de protéines kinases</term><term>Pipérazines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Leukemia, Myelogenous, Chronic, BCR-ABL Positive</term><term>Precursor Cell Lymphoblastic Leukemia-Lymphoma</term></keywords><keywords scheme="MESH" qualifier="génétique" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie-lymphome lymphoblastique à précurseurs B et T</term><term>Protéines de fusion bcr-abl</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Leucémie myéloïde chronique BCR-ABL positive</term><term>Leucémie-lymphome lymphoblastique à précurseurs B et T</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Amino Acid Substitution</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Mutation, Missense</term><term>Philadelphia Chromosome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Chromosome Philadelphie</term><term>Femelle</term><term>Humains</term><term>Mutation faux-sens</term><term>Mâle</term><term>Substitution d'acide aminé</term><term>Sujet âgé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Aurora kinase overexpression has been observed in patients with hematologic malignancies. MK-0457, a pan-aurora kinase inhibitor that also inhibits the ABL T315I mutant, was evaluated to treat patients with chronic myelogenous leukemia (CML) or Philadelphia chromosome (Ph+) acute lymphoblastic leukemia (ALL) with the T315I mutation. Adults with Ph+ chronic phase (CP)-, accelerated phase (AP)- or blast phase (BP)-CML, or ALL and documented BCR-ABL T315I mutation were treated with a 5-day continuous infusion of MK-0457 administered every 14 days at 40 mg/m<sup>2</sup>/h, 32 mg/m<sup>2</sup>/h or 24 mg/m<sup>2</sup>/h. Fifty-two patients (CP, <italic>n</italic>=15; AP, <italic>n</italic>=14; BP, <italic>n</italic>=11; Ph+ ALL, <italic>n</italic>=12) were treated. Overall, 8% of patients achieved major cytogenetic response; 6% achieved unconfirmed complete or partial response; 39% had no response. Two patients (CP CML) achieved complete hematologic response. No patients with advanced CML or Ph+ ALL achieved major hematologic response. The most common adverse event (AE) was neutropenia (50%). The most common grade 3/4 AEs were neutropenia (46%) and febrile neutropenia (35%). MK-0457 demonstrated minimal efficacy and only at higher, intolerable doses; lower doses were tolerated and no unexpected toxicities were observed. 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Dufva</name></noRegion></country><country name="Espagne"><noRegion><name sortKey="Jimenez, J L" sort="Jimenez, J L" uniqKey="Jimenez J" first="J L" last="Jimenez">J L Jimenez</name></noRegion></country><country name="France"><noRegion><name sortKey="Mahon, F X" sort="Mahon, F X" uniqKey="Mahon F" first="F-X" last="Mahon">F-X Mahon</name></noRegion><name sortKey="Rousselot, P" sort="Rousselot, P" uniqKey="Rousselot P" first="P" last="Rousselot">P. Rousselot</name></country><country name="Italie"><noRegion><name sortKey="Martinelli, G" sort="Martinelli, G" uniqKey="Martinelli G" first="G" last="Martinelli">G. Martinelli</name></noRegion><name sortKey="Papayannidis, C" sort="Papayannidis, C" uniqKey="Papayannidis C" first="C" last="Papayannidis">C. Papayannidis</name></country><country name="Israël"><noRegion><name sortKey="Nagler, A" sort="Nagler, A" uniqKey="Nagler A" first="A" last="Nagler">A. 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