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/nm/journal/v14/n9/suppinfo/nm month download article/chapter pan-pi3k/mtor inhibitor oral pan-pi3k bkm120 pi3k/mtor inhibitor gsk2126458 identifying genotype-dependent efficacy pi3k/pten/akt pathways bayesian dose-finding design clinical trials phase ib study clinical trial access combination trials full article pdf dose-escalation trial gi-related toxicities advanced solid tumors received research funding national research committee pi3k/mtor inhibitor privacy choices/manage cookies related subjects allosteric akt inhibitor pi3k inhibitor pictilisib metastatic solid tumors bayesian dose finding circulating mutant dna akt inhibitor ipatasertib akt inhibitor afuresertib dose-escalation study zone-based 3 + 3 design pi3k inhibitor gdc-0941 ras/raf/pi3k mapk/erk kinase oxford ox2 6dp oxford ox5 1gb irccs scientific institute received travel funding mek inhibitor cobimetinib mek inhibitor trametinib mapk-pathway inhibition breast cancer models breast cancer cells article grilley-olson phosphatidylinositol 3-kinase inhibitors medical oncology 1q mek inhibitor gdc-0973 article investigational intermittent dosing cohort maximum tolerated dose european economic area

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         headline:A phase Ib dose-escalation study of the MEK inhibitor trametinib in combination with the PI3K/mTOR inhibitor GSK2126458 in patients with advanced solid tumors
         description: Introduction This Phase Ib trial investigated the safety, tolerability, and recommended phase 2 dose for the pan-PI3K/mTOR inhibitor, GSK2126458 (GSK458), and trametinib combination when administered to patients with advanced solid tumors. Patients and Methods Patients with advanced solid tumors received escalating doses of GSK458 (once or twice daily, and continuous or intermittent) and trametinib following a zone-based 3 + 3 design to determine the maximum tolerated dose (MTD). Assessments included monitoring for adverse events and response, and evaluating pharmacokinetic (PK) measures. Archival tissue and circulating free DNA samples were collected to assess biomarkers of response in the PI3K and RAS pathways. Results 57 patients were enrolled onto the continuous dosing cohort and 12 patients onto an intermittent BID dosing cohort. Two MTDs were established for the continuous daily dosing: 2 mg of GSK458 with 1.0 mg of trametinib or 1.0 mg of GSK458 with 1.5 mg of trametinib; no MTD was determined in the intermittent dosing cohort. The most frequent adverse events were rash (74 %) and diarrhea (61 %). Dose interruptions due to adverse events occurred in 42 % of patients. No significant PK interaction was observed. One patient achieved partial response and 12 patients had stable disease >16 weeks. Mutations in RAS/RAF/PI3K were detected in 70 % of patients, but no pattern emerged between response and mutational status. Conclusion GSK458 plus trametinib is poorly tolerated, due to skin and GI-related toxicities. Responses were minimal, despite enrichment for PI3K/RAS pathway driven tumors, which may be due to overlapping toxicities precluding sufficient dose exposure.
         datePublished:2016-07-23T00:00:00Z
         dateModified:2016-07-23T00:00:00Z
         pageStart:740
         pageEnd:749
         sameAs:https://doi.org/10.1007/s10637-016-0377-0
         keywords:
            Trametinib
            GSK2126458
            MEK inhibitor
            PI3K inhibitor
            Phase I clinical trial
            Oncology
            Pharmacology/Toxicology
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      headline:A phase Ib dose-escalation study of the MEK inhibitor trametinib in combination with the PI3K/mTOR inhibitor GSK2126458 in patients with advanced solid tumors
      description: Introduction This Phase Ib trial investigated the safety, tolerability, and recommended phase 2 dose for the pan-PI3K/mTOR inhibitor, GSK2126458 (GSK458), and trametinib combination when administered to patients with advanced solid tumors. Patients and Methods Patients with advanced solid tumors received escalating doses of GSK458 (once or twice daily, and continuous or intermittent) and trametinib following a zone-based 3 + 3 design to determine the maximum tolerated dose (MTD). Assessments included monitoring for adverse events and response, and evaluating pharmacokinetic (PK) measures. Archival tissue and circulating free DNA samples were collected to assess biomarkers of response in the PI3K and RAS pathways. Results 57 patients were enrolled onto the continuous dosing cohort and 12 patients onto an intermittent BID dosing cohort. Two MTDs were established for the continuous daily dosing: 2 mg of GSK458 with 1.0 mg of trametinib or 1.0 mg of GSK458 with 1.5 mg of trametinib; no MTD was determined in the intermittent dosing cohort. The most frequent adverse events were rash (74 %) and diarrhea (61 %). Dose interruptions due to adverse events occurred in 42 % of patients. No significant PK interaction was observed. One patient achieved partial response and 12 patients had stable disease >16 weeks. Mutations in RAS/RAF/PI3K were detected in 70 % of patients, but no pattern emerged between response and mutational status. Conclusion GSK458 plus trametinib is poorly tolerated, due to skin and GI-related toxicities. Responses were minimal, despite enrichment for PI3K/RAS pathway driven tumors, which may be due to overlapping toxicities precluding sufficient dose exposure.
      datePublished:2016-07-23T00:00:00Z
      dateModified:2016-07-23T00:00:00Z
      pageStart:740
      pageEnd:749
      sameAs:https://doi.org/10.1007/s10637-016-0377-0
      keywords:
         Trametinib
         GSK2126458
         MEK inhibitor
         PI3K inhibitor
         Phase I clinical trial
         Oncology
         Pharmacology/Toxicology
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                  address:
                     name:GlaxoSmithKline Plc, Collegeville, USA
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                  name:RTP
                  address:
                     name:RTP, Durham, USA
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                  address:
                     name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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            name:L. Cartee
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      name:J. E. Grilley-Olson
      affiliation:
            name:University of North Carolina Lineberger Comprehensive Cancer Center
            address:
               name:Division of Hematology/Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, USA
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:P. L. Bedard
      affiliation:
            name:University Health Network- Princess Margaret Cancer Centre and University of Toronto
            address:
               name:University Health Network- Princess Margaret Cancer Centre and University of Toronto, Toronto, Canada
               type:PostalAddress
            type:Organization
      name:A. Fasolo
      affiliation:
            name:IRCCS Scientific Institute
            address:
               name:Unità Nuovi Farmaci e Terapie Innovative Dept. Medical Oncology 1Q-A Ospedale San Raffaele, IRCCS Scientific Institute, Milan, Italy
               type:PostalAddress
            type:Organization
      name:M. Cornfeld
      affiliation:
            name:GlaxoSmithKline Plc
            address:
               name:GlaxoSmithKline Plc, Collegeville, USA
               type:PostalAddress
            type:Organization
            name:RTP
            address:
               name:RTP, Durham, USA
               type:PostalAddress
            type:Organization
            name:Novartis Pharmaceuticals Corporation
            address:
               name:Novartis Pharmaceuticals Corporation, East Hanover, USA
               type:PostalAddress
            type:Organization
      name:L. Cartee
      affiliation:
            name:GlaxoSmithKline Plc
            address:
               name:GlaxoSmithKline Plc, Collegeville, USA
               type:PostalAddress
            type:Organization
            name:RTP
            address:
               name:RTP, Durham, USA
               type:PostalAddress
            type:Organization
            name:UNC Lineberger Comprehensive Cancer Center
            address:
               name:UNC Lineberger Comprehensive Cancer Center, Chapel Hill, USA
               type:PostalAddress
            type:Organization
      name:A. R. Abdul Razak
      affiliation:
            name:University Health Network- Princess Margaret Cancer Centre and University of Toronto
            address:
               name:University Health Network- Princess Margaret Cancer Centre and University of Toronto, Toronto, Canada
               type:PostalAddress
            type:Organization
      name:L.-A. Stayner
      affiliation:
            name:University Health Network- Princess Margaret Cancer Centre and University of Toronto
            address:
               name:University Health Network- Princess Margaret Cancer Centre and University of Toronto, Toronto, Canada
               type:PostalAddress
            type:Organization
      name:Y. Wu
      affiliation:
            name:GlaxoSmithKline Plc
            address:
               name:GlaxoSmithKline Plc, Collegeville, USA
               type:PostalAddress
            type:Organization
            name:RTP
            address:
               name:RTP, Durham, USA
               type:PostalAddress
            type:Organization
      name:R. Greenwood
      affiliation:
            name:GlaxoSmithKline Plc
            address:
               name:GlaxoSmithKline Plc, Collegeville, USA
               type:PostalAddress
            type:Organization
            name:RTP
            address:
               name:RTP, Durham, USA
               type:PostalAddress
            type:Organization
            name:Novartis Pharmaceuticals Corporation
            address:
               name:Novartis Pharmaceuticals Corporation, East Hanover, USA
               type:PostalAddress
            type:Organization
      name:R. Singh
      affiliation:
            name:GlaxoSmithKline Plc
            address:
               name:GlaxoSmithKline Plc, Collegeville, USA
               type:PostalAddress
            type:Organization
            name:RTP
            address:
               name:RTP, Durham, USA
               type:PostalAddress
            type:Organization
      name:C. B. Lee
      affiliation:
            name:University of North Carolina Lineberger Comprehensive Cancer Center
            address:
               name:Division of Hematology/Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, USA
               type:PostalAddress
            type:Organization
      name:J. Bendell
      affiliation:
            name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC
            address:
               name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, USA
               type:PostalAddress
            type:Organization
      name:H. A. Burris
      affiliation:
            name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC
            address:
               name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, USA
               type:PostalAddress
            type:Organization
      name:G. Del Conte
      affiliation:
            name:IRCCS Scientific Institute
            address:
               name:Unità Nuovi Farmaci e Terapie Innovative Dept. Medical Oncology 1Q-A Ospedale San Raffaele, IRCCS Scientific Institute, Milan, Italy
               type:PostalAddress
            type:Organization
      name:C. Sessa
      affiliation:
            name:IRCCS Scientific Institute
            address:
               name:Unità Nuovi Farmaci e Terapie Innovative Dept. Medical Oncology 1Q-A Ospedale San Raffaele, IRCCS Scientific Institute, Milan, Italy
               type:PostalAddress
            type:Organization
      name:J. R. Infante
      affiliation:
            name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC
            address:
               name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, USA
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Division of Hematology/Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, USA
      name:University Health Network- Princess Margaret Cancer Centre and University of Toronto, Toronto, Canada
      name:Unità Nuovi Farmaci e Terapie Innovative Dept. Medical Oncology 1Q-A Ospedale San Raffaele, IRCCS Scientific Institute, Milan, Italy
      name:GlaxoSmithKline Plc, Collegeville, USA
      name:RTP, Durham, USA
      name:Novartis Pharmaceuticals Corporation, East Hanover, USA
      name:GlaxoSmithKline Plc, Collegeville, USA
      name:RTP, Durham, USA
      name:UNC Lineberger Comprehensive Cancer Center, Chapel Hill, USA
      name:University Health Network- Princess Margaret Cancer Centre and University of Toronto, Toronto, Canada
      name:University Health Network- Princess Margaret Cancer Centre and University of Toronto, Toronto, Canada
      name:GlaxoSmithKline Plc, Collegeville, USA
      name:RTP, Durham, USA
      name:GlaxoSmithKline Plc, Collegeville, USA
      name:RTP, Durham, USA
      name:Novartis Pharmaceuticals Corporation, East Hanover, USA
      name:GlaxoSmithKline Plc, Collegeville, USA
      name:RTP, Durham, USA
      name:Division of Hematology/Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, USA
      name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, USA
      name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, USA
      name:Unità Nuovi Farmaci e Terapie Innovative Dept. Medical Oncology 1Q-A Ospedale San Raffaele, IRCCS Scientific Institute, Milan, Italy
      name:Unità Nuovi Farmaci e Terapie Innovative Dept. Medical Oncology 1Q-A Ospedale San Raffaele, IRCCS Scientific Institute, Milan, Italy
      name:Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, USA
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