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Keywords {🔍}

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Topics {✒️}

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Schema {🗺️}

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         headline:A Multi-Arm Phase I Study of the PI3K/mTOR Inhibitors PF-04691502 and Gedatolisib (PF-05212384) plus Irinotecan or the MEK Inhibitor PD-0325901 in Advanced Cancer
         description:This phase I, four-arm, open-label study (NCT01347866) evaluated the PI3K/mTOR inhibitors PF-04691502 (arms A, B) and gedatolisib (PF-05212384; arms C, D) in combination with the MEK inhibitor PD-0325901 (arm A, D) or irinotecan (arm B, C) in patients with advanced solid tumors. Primary endpoint was dose-limiting toxicity with each combination. Secondary endpoints included safety, pharmacokinetics and preliminary antitumor activity. Dose escalation followed a 3 + 3 design in arm C and a zone-based design in arm D. The PF-04691502 combination arms were closed prematurely due to low tolerability, and the maximum tolerated doses (MTDs) were not determined for either arm. The MTD for the combination of gedatolisib with irinotecan 180 mg/m2 was estimated to be 110 mg weekly and for the combination with PD-0325901 was not reached at the highest dose evaluated (gedatolisib 154 mg weekly). Plasma concentrations of gedatolisib were generally similar across dose groups in arm C (with irinotecan) and arm D (with PD-0325901). Frequent dose delays or dose reductions were required for both combinations, potentially preventing sustained therapeutic drug concentrations. Gedatolisib plus irinotecan produced a response rate of ~5% and clinical benefit in 16% of patients with advanced colorectal cancer (progression-free survival, 2.8 months). Preliminary evidence of clinical activity was observed with gedatolisib plus PD-0325901 in patients with ovarian cancer (three partial responses, n = 5) or endometrial cancer (one partial response, n = 1) and KRAS mutations. Further evaluations of gedatolisib are warranted in patients with advanced solid malignancies.
         datePublished:2017-10-24T00:00:00Z
         dateModified:2017-10-24T00:00:00Z
         pageStart:775
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      headline:A Multi-Arm Phase I Study of the PI3K/mTOR Inhibitors PF-04691502 and Gedatolisib (PF-05212384) plus Irinotecan or the MEK Inhibitor PD-0325901 in Advanced Cancer
      description:This phase I, four-arm, open-label study (NCT01347866) evaluated the PI3K/mTOR inhibitors PF-04691502 (arms A, B) and gedatolisib (PF-05212384; arms C, D) in combination with the MEK inhibitor PD-0325901 (arm A, D) or irinotecan (arm B, C) in patients with advanced solid tumors. Primary endpoint was dose-limiting toxicity with each combination. Secondary endpoints included safety, pharmacokinetics and preliminary antitumor activity. Dose escalation followed a 3 + 3 design in arm C and a zone-based design in arm D. The PF-04691502 combination arms were closed prematurely due to low tolerability, and the maximum tolerated doses (MTDs) were not determined for either arm. The MTD for the combination of gedatolisib with irinotecan 180 mg/m2 was estimated to be 110 mg weekly and for the combination with PD-0325901 was not reached at the highest dose evaluated (gedatolisib 154 mg weekly). Plasma concentrations of gedatolisib were generally similar across dose groups in arm C (with irinotecan) and arm D (with PD-0325901). Frequent dose delays or dose reductions were required for both combinations, potentially preventing sustained therapeutic drug concentrations. Gedatolisib plus irinotecan produced a response rate of ~5% and clinical benefit in 16% of patients with advanced colorectal cancer (progression-free survival, 2.8 months). Preliminary evidence of clinical activity was observed with gedatolisib plus PD-0325901 in patients with ovarian cancer (three partial responses, n = 5) or endometrial cancer (one partial response, n = 1) and KRAS mutations. Further evaluations of gedatolisib are warranted in patients with advanced solid malignancies.
      datePublished:2017-10-24T00:00:00Z
      dateModified:2017-10-24T00:00:00Z
      pageStart:775
      pageEnd:785
      sameAs:https://doi.org/10.1007/s11523-017-0530-5
      keywords:
         Oncology
         Biomedicine
         general
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            name:Zev A. Wainberg
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            name:Maria Alsina
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                  address:
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                  name:Medical University of South Carolina
                  address:
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            name:Gianluca Del Conte
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            address:
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               type:PostalAddress
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      name:Carolyn D. Britten
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            address:
               name:Medical University of South Carolina, Charleston, USA
               type:PostalAddress
            type:Organization
      name:Gianluca Del Conte
      affiliation:
            name:IRCCS Ospedale S. Raffaele
            address:
               name:IRCCS Ospedale S. Raffaele, Milan, Italy
               type:PostalAddress
            type:Organization
      name:Patrick Ezeh
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            name:Pfizer Oncology
            address:
               name:Pfizer Oncology, Cambridge, USA
               type:PostalAddress
            type:Organization
      name:Brett Houk
      affiliation:
            name:Pfizer Oncology
            address:
               name:Pfizer Oncology, San Diego, USA
               type:PostalAddress
            type:Organization
      name:Kenneth A. Kern
      affiliation:
            name:Pfizer Oncology
            address:
               name:Pfizer Oncology, San Diego, USA
               type:PostalAddress
            type:Organization
      name:Stephen Leong
      affiliation:
            name:University of Colorado Denver School of Medicine
            address:
               name:University of Colorado Denver School of Medicine, Aurora, USA
               type:PostalAddress
            type:Organization
      name:Nuzhat Pathan
      affiliation:
            name:Pfizer Oncology
            address:
               name:Pfizer Oncology, San Diego, USA
               type:PostalAddress
            type:Organization
      name:Kristen J. Pierce
      affiliation:
            name:Pfizer Oncology
            address:
               name:Pfizer Oncology, Groton, USA
               type:PostalAddress
            type:Organization
      name:Lillian L. Siu
      affiliation:
            name:Princess Margaret Cancer Centre
            address:
               name:Princess Margaret Cancer Centre, Toronto, Canada
               type:PostalAddress
            type:Organization
      name:Jennifer Vermette
      affiliation:
            name:Pfizer Oncology
            address:
               name:Pfizer Oncology, Cambridge, USA
               type:PostalAddress
            type:Organization
      name:Josep Tabernero
      affiliation:
            name:Universitat Autònoma de Barcelona
            address:
               name:Vall d’Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain
               type:PostalAddress
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      name:David Geffen School of Medicine at UCLA, Los Angeles, USA
      name:Vall d’Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain
      name:Moffitt Cancer Center, Tampa, USA
      name:Princess Margaret Cancer Centre, Toronto, Canada
      name:Medical University of South Carolina, Charleston, USA
      name:IRCCS Ospedale S. Raffaele, Milan, Italy
      name:Pfizer Oncology, Cambridge, USA
      name:Pfizer Oncology, San Diego, USA
      name:Pfizer Oncology, San Diego, USA
      name:University of Colorado Denver School of Medicine, Aurora, USA
      name:Pfizer Oncology, San Diego, USA
      name:Pfizer Oncology, Groton, USA
      name:Princess Margaret Cancer Centre, Toronto, Canada
      name:Pfizer Oncology, Cambridge, USA
      name:Vall d’Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain

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