Phase I safety, pharmacokinetic, and pharmacodynamic study of SAR245409 (XL765), a novel, orally administered PI3K/mTOR inhibitor in patients with advanced solid tumors.
Identifieur interne : 003706 ( PubMed/Curation ); précédent : 003705; suivant : 003707Phase I safety, pharmacokinetic, and pharmacodynamic study of SAR245409 (XL765), a novel, orally administered PI3K/mTOR inhibitor in patients with advanced solid tumors.
Auteurs : Kyriakos P. Papadopoulos [France] ; Josep Tabernero ; Ben Markman ; Amita Patnaik ; Anthony W. Tolcher ; José Baselga ; Weiliang Shi ; Coumaran Egile ; Rodrigo Ruiz-Soto ; A Douglas Laird ; Dale Miles ; Patricia M. LorussoSource :
- Clinical cancer research : an official journal of the American Association for Cancer Research [ 1078-0432 ] ; 2014.
Descripteurs français
- KwdFr :
- Administration par voie orale, Adulte, Adulte d'âge moyen, Antinéoplasiques (pharmacologie), Antinéoplasiques (usage thérapeutique), Dose maximale tolérée, Femelle, Humains, Jeune adulte, Mâle, Phosphatidylinositol 3-kinases (antagonistes et inhibiteurs), Quinoxalines (pharmacologie), Quinoxalines (usage thérapeutique), Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Sujet âgé de 80 ans ou plus, Sulfonamides (pharmacologie), Sulfonamides (usage thérapeutique), Surveillance pharmacologique, Sérine-thréonine kinases TOR (antagonistes et inhibiteurs), Transduction du signal (), Tumeurs (anatomopathologie), Tumeurs (métabolisme), Tumeurs (traitement médicamenteux).
- MESH :
- anatomopathologie : Tumeurs.
- antagonistes et inhibiteurs : Phosphatidylinositol 3-kinases, Sérine-thréonine kinases TOR.
- métabolisme : Tumeurs.
- pharmacologie : Antinéoplasiques, Quinoxalines, Sulfonamides.
- traitement médicamenteux : Tumeurs.
- usage thérapeutique : Antinéoplasiques, Quinoxalines, Sulfonamides.
- Administration par voie orale, Adulte, Adulte d'âge moyen, Dose maximale tolérée, Femelle, Humains, Jeune adulte, Mâle, Résultat thérapeutique, Stade de la tumeur, Sujet âgé, Sujet âgé de 80 ans ou plus, Surveillance pharmacologique, Transduction du signal.
English descriptors
- KwdEn :
- Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Agents (pharmacology), Antineoplastic Agents (therapeutic use), Drug Monitoring, Female, Humans, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Staging, Neoplasms (drug therapy), Neoplasms (metabolism), Neoplasms (pathology), Phosphatidylinositol 3-Kinases (antagonists & inhibitors), Quinoxalines (pharmacology), Quinoxalines (therapeutic use), Signal Transduction (drug effects), Sulfonamides (pharmacology), Sulfonamides (therapeutic use), TOR Serine-Threonine Kinases (antagonists & inhibitors), Treatment Outcome, Young Adult.
- MESH :
- chemical , antagonists & inhibitors : Phosphatidylinositol 3-Kinases, TOR Serine-Threonine Kinases.
- chemical , pharmacology : Antineoplastic Agents, Quinoxalines, Sulfonamides.
- chemical , therapeutic use : Antineoplastic Agents, Quinoxalines, Sulfonamides.
- drug effects : Signal Transduction.
- drug therapy : Neoplasms.
- metabolism : Neoplasms.
- pathology : Neoplasms.
- Administration, Oral, Adult, Aged, Aged, 80 and over, Drug Monitoring, Female, Humans, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Staging, Treatment Outcome, Young Adult.
Abstract
This phase I, first-in-human study evaluated the safety, maximum-tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary efficacy of SAR245409, an inhibitor of pan-Class I phosphoinositide 3-kinase (PI3K) and mTOR, administered orally once or twice daily in patients with advanced solid tumors.
DOI: 10.1158/1078-0432.CCR-13-2403
PubMed: 24583798
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pubmed:24583798Le document en format XML
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Papadopoulos</name><affiliation wicri:level="1"><nlm:affiliation>Authors' Affiliations: South Texas Accelerated Research Therapeutics, San Antonio, Texas; Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, New York; Sanofi, Cambridge, Massachusetts; Exelixis Inc., South San Francisco, California; Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain; Monash Institute of Medical Research, Monash University, Melbourne, Victoria, Australia; and Sanofi, Vitry-sur-Seine, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Authors' Affiliations: South Texas Accelerated Research Therapeutics, San Antonio, Texas; Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, New York; Sanofi, Cambridge, Massachusetts; Exelixis Inc., South San Francisco, California; Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain; Monash Institute of Medical Research, Monash University, Melbourne, Victoria, Australia; and Sanofi, Vitry-sur-Seine</wicri:regionArea></affiliation></author><author><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name></author><author><name sortKey="Markman, Ben" sort="Markman, Ben" uniqKey="Markman B" first="Ben" last="Markman">Ben Markman</name></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name></author><author><name sortKey="Tolcher, Anthony W" sort="Tolcher, Anthony W" uniqKey="Tolcher A" first="Anthony W" last="Tolcher">Anthony W. 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Papadopoulos</name><affiliation wicri:level="1"><nlm:affiliation>Authors' Affiliations: South Texas Accelerated Research Therapeutics, San Antonio, Texas; Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, New York; Sanofi, Cambridge, Massachusetts; Exelixis Inc., South San Francisco, California; Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain; Monash Institute of Medical Research, Monash University, Melbourne, Victoria, Australia; and Sanofi, Vitry-sur-Seine, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Authors' Affiliations: South Texas Accelerated Research Therapeutics, San Antonio, Texas; Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, New York; Sanofi, Cambridge, Massachusetts; Exelixis Inc., South San Francisco, California; Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain; Monash Institute of Medical Research, Monash University, Melbourne, Victoria, Australia; and Sanofi, Vitry-sur-Seine</wicri:regionArea></affiliation></author><author><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name></author><author><name sortKey="Markman, Ben" sort="Markman, Ben" uniqKey="Markman B" first="Ben" last="Markman">Ben Markman</name></author><author><name sortKey="Patnaik, Amita" sort="Patnaik, Amita" uniqKey="Patnaik A" first="Amita" last="Patnaik">Amita Patnaik</name></author><author><name sortKey="Tolcher, Anthony W" sort="Tolcher, Anthony W" uniqKey="Tolcher A" first="Anthony W" last="Tolcher">Anthony W. 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type="abstract" xml:lang="en">This phase I, first-in-human study evaluated the safety, maximum-tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary efficacy of SAR245409, an inhibitor of pan-Class I phosphoinositide 3-kinase (PI3K) and mTOR, administered orally once or twice daily in patients with advanced solid tumors.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24583798</PMID><DateCreated><Year>2014</Year><Month>05</Month><Day>05</Day></DateCreated><DateCompleted><Year>2015</Year><Month>08</Month><Day>20</Day></DateCompleted><DateRevised><Year>2014</Year><Month>05</Month><Day>05</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">1078-0432</ISSN><JournalIssue CitedMedium="Internet"><Volume>20</Volume><Issue>9</Issue><PubDate><Year>2014</Year><Month>May</Month><Day>01</Day></PubDate></JournalIssue><Title>Clinical cancer research : an official journal of the American Association for Cancer Research</Title><ISOAbbreviation>Clin. Cancer Res.</ISOAbbreviation></Journal><ArticleTitle>Phase I safety, pharmacokinetic, and pharmacodynamic study of SAR245409 (XL765), a novel, orally administered PI3K/mTOR inhibitor in patients with advanced solid tumors.</ArticleTitle><Pagination><MedlinePgn>2445-56</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1158/1078-0432.CCR-13-2403</ELocationID><Abstract><AbstractText Label="PURPOSE" NlmCategory="OBJECTIVE">This phase I, first-in-human study evaluated the safety, maximum-tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary efficacy of SAR245409, an inhibitor of pan-Class I phosphoinositide 3-kinase (PI3K) and mTOR, administered orally once or twice daily in patients with advanced solid tumors.</AbstractText><AbstractText Label="EXPERIMENTAL DESIGN" NlmCategory="METHODS">Eighty-three patients received SAR245409. Doses ranged from 15 to 120 mg twice daily, and 70 to 100 mg once daily. A 3+3 dose-escalation design was used to determine the MTD. Patients were evaluated for adverse events and response. Assessments included pharmacokinetic, pharmacodynamic impact of SAR245409 on PI3K pathway signaling in hair sheath cells, skin and tumor, and characterization of tumor molecular alterations.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The MTDs were 50 mg twice daily and 90 mg once daily. The most frequent treatment-related adverse events were nausea (36.1%), diarrhea (21.7%), vomiting (19.3%), and decreased appetite (16.9%). The most frequent treatment-related grade 3/4 adverse events were increases in alanine aminotransferase (6.0%) and aspartate aminotransferase (4.8%). SAR245409 had a relatively short plasma half-life (2.96-7.52 hours). At MTDs, once- and twice-daily regimens yielded similar mean steady-state plasma exposure. A reduction in PI3K and mTORC1/mTORC2 pathway signaling was observed in serial hair sheath cells, skin, and tumor samples. Best response was stable disease in 48% of evaluable patients; seven patients had minor tumor regression. Twelve patients with stable disease were treated for ≥16 weeks. No trend was observed correlating tumor molecular alteration with antitumor activity.</AbstractText><AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">SAR245409 had a manageable safety profile, demonstrated reduced PI3K and mTORC1/mTORC2 pathway signaling and was associated with clinically relevant stable disease.</AbstractText><CopyrightInformation>©2014 AACR.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Papadopoulos</LastName><ForeName>Kyriakos P</ForeName><Initials>KP</Initials><AffiliationInfo><Affiliation>Authors' Affiliations: South Texas Accelerated Research Therapeutics, San Antonio, Texas; Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, New York; Sanofi, Cambridge, Massachusetts; Exelixis Inc., South San Francisco, California; Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, Michigan; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain; Monash Institute of Medical Research, Monash University, Melbourne, Victoria, Australia; and Sanofi, Vitry-sur-Seine, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tabernero</LastName><ForeName>Josep</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Markman</LastName><ForeName>Ben</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Patnaik</LastName><ForeName>Amita</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Tolcher</LastName><ForeName>Anthony W</ForeName><Initials>AW</Initials></Author><Author ValidYN="Y"><LastName>Baselga</LastName><ForeName>José</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Shi</LastName><ForeName>Weiliang</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Egile</LastName><ForeName>Coumaran</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Ruiz-Soto</LastName><ForeName>Rodrigo</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Laird</LastName><ForeName>A Douglas</ForeName><Initials>AD</Initials></Author><Author ValidYN="Y"><LastName>Miles</LastName><ForeName>Dale</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Lorusso</LastName><ForeName>Patricia M</ForeName><Initials>PM</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017426">Clinical Trial, Phase I</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>02</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Cancer Res</MedlineTA><NlmUniqueID>9502500</NlmUniqueID><ISSNLinking>1078-0432</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011810">Quinoxalines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D013449">Sulfonamides</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="C576808">XL765</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.1.-</RegistryNumber><NameOfSubstance UI="D019869">Phosphatidylinositol 3-Kinases</NameOfSubstance></Chemical><Chemical><RegistryNumber>EC 2.7.1.1</RegistryNumber><NameOfSubstance UI="D058570">TOR Serine-Threonine Kinases</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000284" MajorTopicYN="N">Administration, Oral</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016903" MajorTopicYN="N">Drug Monitoring</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020714" MajorTopicYN="N">Maximum Tolerated Dose</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009367" MajorTopicYN="N">Neoplasm Staging</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009369" MajorTopicYN="N">Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000378" MajorTopicYN="N">metabolism</QualifierName><QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019869" MajorTopicYN="N">Phosphatidylinositol 3-Kinases</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D011810" MajorTopicYN="N">Quinoxalines</DescriptorName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015398" MajorTopicYN="N">Signal Transduction</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013449" MajorTopicYN="N">Sulfonamides</DescriptorName><QualifierName UI="Q000494" MajorTopicYN="Y">pharmacology</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D058570" MajorTopicYN="N">TOR Serine-Threonine Kinases</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>3</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>3</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2015</Year><Month>8</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24583798</ArticleId><ArticleId IdType="pii">1078-0432.CCR-13-2403</ArticleId><ArticleId IdType="doi">10.1158/1078-0432.CCR-13-2403</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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