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Questions {❓}

• Nancey S, Boschetti G, Cotte E, Ruel K, Almeras T, Chauvenet M et al (2012) Blockade of cytotoxic T-lymphocyte antigen-4 by ipilimumab is associated with a profound long-lasting depletion of Foxp3+ regulatory T cells: a mechanistic explanation for ipilimumab-induced severe enterocolitis?

Schema {🗺️}

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         headline:Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer
         description: Purpose Transforming growth factor-beta (TGF-β) signaling plays a key role in epithelial-mesenchymal transition (EMT) of tumors, including malignant glioma. Small molecule inhibitors (SMI) blocking TGF-β signaling reverse EMT and arrest tumor progression. Several SMIs were developed, but currently only LY2157299 monohydrate (galunisertib) was advanced to clinical investigation. Design The first-in-human dose study had three parts (Part A, dose escalation, n = 39; Part B, safety combination with lomustine, n = 26; Part C, relative bioavailability study, n = 14). Results A preclinical pharmacokinetic/pharmacodynamic (PK/PD) model predicted a therapeutic window up to 300 mg/day and was confirmed in Part A after continuous PK/PD. PK was not affected by co-medications such as enzyme-inducing anti-epileptic drugs or proton pump inhibitors. Changes in pSMAD2 levels in peripheral blood mononuclear cells were associated with exposure indicating target-related pharmacological activity of galunisertib. Twelve (12/79; 15 %) patients with refractory/relapsed malignant glioma had durable stable disease (SD) for 6 or more cycles, partial responses (PR), or complete responses (CR). These patients with clinical benefit had high plasma baseline levels of MDC/CCL22 and low protein expression of pSMAD2 in their tumors. Of the 5 patients with IDH1/2 mutation, 4 patients had a clinical benefit as defined by CR/PR and SD ≥6 cycles. Galunisertib had a favorable toxicity profile and no cardiac adverse events. Conclusion Based on the PK, PD, and biomarker evaluations, the intermittent administration of galunisertib at 300 mg/day is safe for future clinical investigation.
         datePublished:2014-12-23T00:00:00Z
         dateModified:2014-12-23T00:00:00Z
         pageStart:357
         pageEnd:370
         sameAs:https://doi.org/10.1007/s10637-014-0192-4
         keywords:
            TGF-β inhibitor
            Galunisertib
            First-in-Human Dose
            Glioma
            Pharmacokinetics
            Pharmacodynamics
            Oncology
            Pharmacology/Toxicology
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      headline:Pharmacokinetic, pharmacodynamic and biomarker evaluation of transforming growth factor-β receptor I kinase inhibitor, galunisertib, in phase 1 study in patients with advanced cancer
      description: Purpose Transforming growth factor-beta (TGF-β) signaling plays a key role in epithelial-mesenchymal transition (EMT) of tumors, including malignant glioma. Small molecule inhibitors (SMI) blocking TGF-β signaling reverse EMT and arrest tumor progression. Several SMIs were developed, but currently only LY2157299 monohydrate (galunisertib) was advanced to clinical investigation. Design The first-in-human dose study had three parts (Part A, dose escalation, n = 39; Part B, safety combination with lomustine, n = 26; Part C, relative bioavailability study, n = 14). Results A preclinical pharmacokinetic/pharmacodynamic (PK/PD) model predicted a therapeutic window up to 300 mg/day and was confirmed in Part A after continuous PK/PD. PK was not affected by co-medications such as enzyme-inducing anti-epileptic drugs or proton pump inhibitors. Changes in pSMAD2 levels in peripheral blood mononuclear cells were associated with exposure indicating target-related pharmacological activity of galunisertib. Twelve (12/79; 15 %) patients with refractory/relapsed malignant glioma had durable stable disease (SD) for 6 or more cycles, partial responses (PR), or complete responses (CR). These patients with clinical benefit had high plasma baseline levels of MDC/CCL22 and low protein expression of pSMAD2 in their tumors. Of the 5 patients with IDH1/2 mutation, 4 patients had a clinical benefit as defined by CR/PR and SD ≥6 cycles. Galunisertib had a favorable toxicity profile and no cardiac adverse events. Conclusion Based on the PK, PD, and biomarker evaluations, the intermittent administration of galunisertib at 300 mg/day is safe for future clinical investigation.
      datePublished:2014-12-23T00:00:00Z
      dateModified:2014-12-23T00:00:00Z
      pageStart:357
      pageEnd:370
      sameAs:https://doi.org/10.1007/s10637-014-0192-4
      keywords:
         TGF-β inhibitor
         Galunisertib
         First-in-Human Dose
         Glioma
         Pharmacokinetics
         Pharmacodynamics
         Oncology
         Pharmacology/Toxicology
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            name:Joan Seoane
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                  address:
                     name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
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            name:Irene Braña
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                  name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
                  address:
                     name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
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                  name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
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            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
            name:Hospital Universitari Vall d’Hebron, Vall d’Hebron Institute of Oncology (V.H.I.O.)
            address:
               name:Servei d’Oncologia Medica, Hospital Universitari Vall d’Hebron, Vall d’Hebron Institute of Oncology (V.H.I.O.), Barcelona, Spain
               type:PostalAddress
            type:Organization
      email:[email protected]
      name:Michael Carducci
      affiliation:
            name:Johns Hopkins Kimmel Cancer Center
            address:
               name:Johns Hopkins Kimmel Cancer Center, Baltimore, USA
               type:PostalAddress
            type:Organization
      name:Juan M. Sepulveda-Sánchez
      affiliation:
            name:Hospital Universitario 12 de Octubre
            address:
               name:Hospital Universitario 12 de Octubre, Madrid, Spain
               type:PostalAddress
            type:Organization
      name:Analía Azaro
      affiliation:
            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
      name:Emiliano Calvo
      affiliation:
            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
            name:Centro Integral Oncológico Clara Campal
            address:
               name:START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain
               type:PostalAddress
            type:Organization
      name:Joan Seoane
      affiliation:
            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
      name:Irene Braña
      affiliation:
            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
      name:Elisabet Sicart
      affiliation:
            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
      name:Ivelina Gueorguieva
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Erl Wood, UK
               type:PostalAddress
            type:Organization
      name:Ann Cleverly
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Erl Wood, UK
               type:PostalAddress
            type:Organization
      name:N. Sokalingum Pillay
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:Durisala Desaiah
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:Shawn T. Estrem
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:Luis Paz-Ares
      affiliation:
            name:Hospital Virgen del Rocío
            address:
               name:Hospital Virgen del Rocío, Sevilla, Spain
               type:PostalAddress
            type:Organization
      name:Matthias Holdhoff
      affiliation:
            name:Johns Hopkins Kimmel Cancer Center
            address:
               name:Johns Hopkins Kimmel Cancer Center, Baltimore, USA
               type:PostalAddress
            type:Organization
      name:Jaishri Blakeley
      affiliation:
            name:Johns Hopkins University
            address:
               name:Neurology/Neurosurgery/and Oncology, Johns Hopkins University, Baltimore, USA
               type:PostalAddress
            type:Organization
      name:Michael M. Lahn
      affiliation:
            name:Eli Lilly and Company
            address:
               name:Eli Lilly and Company, Indianapolis, USA
               type:PostalAddress
            type:Organization
      name:Jose Baselga
      affiliation:
            name:Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona
            address:
               name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
               type:PostalAddress
            type:Organization
PostalAddress:
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
      name:Servei d’Oncologia Medica, Hospital Universitari Vall d’Hebron, Vall d’Hebron Institute of Oncology (V.H.I.O.), Barcelona, Spain
      name:Johns Hopkins Kimmel Cancer Center, Baltimore, USA
      name:Hospital Universitario 12 de Octubre, Madrid, Spain
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
      name:START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain
      name:Eli Lilly and Company, Erl Wood, UK
      name:Eli Lilly and Company, Erl Wood, UK
      name:Eli Lilly and Company, Indianapolis, USA
      name:Eli Lilly and Company, Indianapolis, USA
      name:Eli Lilly and Company, Indianapolis, USA
      name:Hospital Virgen del Rocío, Sevilla, Spain
      name:Johns Hopkins Kimmel Cancer Center, Baltimore, USA
      name:Neurology/Neurosurgery/and Oncology, Johns Hopkins University, Baltimore, USA
      name:Eli Lilly and Company, Indianapolis, USA
      name:Medical Oncology, Vall d’Hebron University Hospital and Universitat Autonoma de Barcelona, Barcelona, Spain

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