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tumour-necrosis factor superfamily month download article/chapter inoperable oesophago-gastric adenocarcinoma /ii open-label dose-escalation study efficient dose escalation related subjects phase ii trial cytotoxic ligand trail antibody targeting trail-r1 dr5 antibody lby135 overcomes drug resistance drug development unit targeting apoptosis pathways full article pdf targeting death serum apoptosis product privacy choices/manage cookies stable disease dose-limiting toxicities oncology trials van der kuip provided manuscript development dr5 antibody advanced solid tumors article sharma maximum tolerated dose maximal dose administered double-blind study prospective pilot study novartis pharmaceuticals corporation advanced solid malignancies clinical trials check access instant access article investigational apo2l/trail european economic area elimination half-life m30/m65 levels previously treated adults medical writing services salt lake city refractory colorectal cancer conditions privacy policy sunil sharma fdg-pet responses metastatic breast cancer neoadjuvant chemotherapy accepting optional cookies

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WebPage:
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         headline:Safety, pharmacokinetics, and pharmacodynamics of the DR5 antibody LBY135 alone and in combination with capecitabine in patients with advanced solid tumors
         description: Purpose We evaluated the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, biologic activity, and antitumor efficacy of the DR5 antibody, LBY135 ± capecitabine. Experimental design Escalating LBY135 was administered every 21 days, alone (Arm1) or with capecitabine (Arm2), to patients with advanced solid tumors. Results In Arm1 (n = 40), LBY135 (0.3–40 mg/kg) resulted in no dose-limiting toxicities (DLTs); adverse events (AEs) included fatigue, hypotension, abdominal pain, dyspnea, and nausea. Stable disease (SD) was observed in 21/38 (55.3 %) patients. In Arm2 (n = 33), LBY135 (1–40 mg/kg) plus capecitabine resulted in 3 DLTs (each grade 3): dehydration and mucosal inflammation (1 mg/kg), colitis (20 mg/kg), and diarrhea (40 mg/kg). AEs included fatigue, nausea, dyspnea, and vomiting. Partial response was observed in 2 patients (rectal and breast cancer) and SD in 12/27 (44.4 %) patients. Mean elimination half-life of LBY135 ± capecitabine at saturation of clearance (≥10 mg/kg) ranged between 146 h and 492 h. Immunogenicity was detected in 16/73 (22 %) patients, of which 6 patients experienced reduced LBY135 exposure with repeat dosing. M30/M65 levels were not predictive for LBY135 response. FDG-PET responses were not consistently associated with RECIST responses. Conclusions LBY135 was well tolerated up to 40 mg/kg, the maximal dose administered; no MTD for LBY135 ± capecitabine was defined. Clearance was saturated at doses ≥10 mg/kg.
         datePublished:2013-04-16T00:00:00Z
         dateModified:2013-04-16T00:00:00Z
         pageStart:135
         pageEnd:144
         sameAs:https://doi.org/10.1007/s10637-013-9952-9
         keywords:
            LBY135
            Dose escalation
            Capecitabine
            DR5
            Death receptor
            TNF-related apoptosis-inducing ligand
            Oncology
            Pharmacology/Toxicology
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         author:
               name:Sunil Sharma
               affiliation:
                     name:University of Utah
                     address:
                        name:Huntsman Cancer Institute, Division of Medical Oncology, University of Utah, Salt Lake City, USA
                        type:PostalAddress
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                        name:University Medical Center Groningen, Groningen, The Netherlands
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                        name:Sarah Cannon Research Institute/ Tennessee Oncology, PLLC (Drug Development Unit), Nashville, USA
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                        name:University Medical Center Groningen, Groningen, The Netherlands
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               name:Lin Yang
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                     name:Novartis Pharmaceuticals Corporation
                     address:
                        name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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                     address:
                        name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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               name:Katie Parker
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                     address:
                        name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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               name:Michael Goldbrunner
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                     address:
                        name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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                        name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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      headline:Safety, pharmacokinetics, and pharmacodynamics of the DR5 antibody LBY135 alone and in combination with capecitabine in patients with advanced solid tumors
      description: Purpose We evaluated the safety, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics, biologic activity, and antitumor efficacy of the DR5 antibody, LBY135 ± capecitabine. Experimental design Escalating LBY135 was administered every 21 days, alone (Arm1) or with capecitabine (Arm2), to patients with advanced solid tumors. Results In Arm1 (n = 40), LBY135 (0.3–40 mg/kg) resulted in no dose-limiting toxicities (DLTs); adverse events (AEs) included fatigue, hypotension, abdominal pain, dyspnea, and nausea. Stable disease (SD) was observed in 21/38 (55.3 %) patients. In Arm2 (n = 33), LBY135 (1–40 mg/kg) plus capecitabine resulted in 3 DLTs (each grade 3): dehydration and mucosal inflammation (1 mg/kg), colitis (20 mg/kg), and diarrhea (40 mg/kg). AEs included fatigue, nausea, dyspnea, and vomiting. Partial response was observed in 2 patients (rectal and breast cancer) and SD in 12/27 (44.4 %) patients. Mean elimination half-life of LBY135 ± capecitabine at saturation of clearance (≥10 mg/kg) ranged between 146 h and 492 h. Immunogenicity was detected in 16/73 (22 %) patients, of which 6 patients experienced reduced LBY135 exposure with repeat dosing. M30/M65 levels were not predictive for LBY135 response. FDG-PET responses were not consistently associated with RECIST responses. Conclusions LBY135 was well tolerated up to 40 mg/kg, the maximal dose administered; no MTD for LBY135 ± capecitabine was defined. Clearance was saturated at doses ≥10 mg/kg.
      datePublished:2013-04-16T00:00:00Z
      dateModified:2013-04-16T00:00:00Z
      pageStart:135
      pageEnd:144
      sameAs:https://doi.org/10.1007/s10637-013-9952-9
      keywords:
         LBY135
         Dose escalation
         Capecitabine
         DR5
         Death receptor
         TNF-related apoptosis-inducing ligand
         Oncology
         Pharmacology/Toxicology
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         name:Springer US
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      author:
            name:Sunil Sharma
            affiliation:
                  name:University of Utah
                  address:
                     name:Huntsman Cancer Institute, Division of Medical Oncology, University of Utah, Salt Lake City, USA
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            name:Jeffrey R. Infante
            affiliation:
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                  address:
                     name:Sarah Cannon Research Institute/ Tennessee Oncology, PLLC (Drug Development Unit), Nashville, USA
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            name:Corina N. Oldenhuis
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            name:Jourik A. Gietema
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            name:Lin Yang
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      name:Jourik A. Gietema
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            address:
               name:University Medical Center Groningen, Groningen, The Netherlands
               type:PostalAddress
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      name:Lin Yang
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            address:
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               name:Sarah Cannon Research Institute/ Tennessee Oncology, PLLC (Drug Development Unit), Nashville, USA
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      name:Novartis Pharmaceuticals Corporation, East Hanover, USA
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