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10.1038/bjc.2014.290 http://scihub22266oqcxt.onion/10.1038/bjc.2014.290 C4102944!4102944 !24901237     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=24901237 &cmd=llinks): Failed to open stream: HTTP request failed! 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Phase I ficlatuzumab monotherapy or with erlotinib for refractory advanced solid tumours and multiple myeloma |pdf=|usr=}}{{24901237 }} gab.com Text Phase I ficlatuzumab monotherapy or with erlotinib for refractory advanced solid tumours and multiple myeloma JO: Br J Cancer http://www.kidney.de/pget.php?&tw=1&pmid=24901237 #FOAvip BACKGROUND: Ficlatuzumab, a humanised hepatocyte growth factor (HGF) IgG1? inhibitory monoclonal antibody, was evaluated for recommended phase II dose (RP2D), safety, pharmacokinetics (PKs), antidrug antibody (ADA), pharmacodynamics (PDs) and antitumour activity as monotherapy or combined with erlotinib. METHODS: Patients with solid tumours received ficlatuzumab 2, 5, 10 or 20?mg?kg(-1) intravenously every 2 weeks (q2w). Additional patients were treated at the RP2D erlotinib. RESULTS: Forty-one patients enrolled at doses ?20?mg?kg(-1). Common adverse events (AEs) included peripheral oedema, fatigue and nausea. Three patients experienced grade ?3 treatment-related hyperkalaemia/hypokalaemia, diarrhoea or fatigue. Best overall response (44%) was stable disease (SD); median duration was 5.5 months (0.4-18.7 months). One patient has been on therapy with SD for >4 years. Pharmacokinetics of ficlatuzumab showed low clearance (0.17-0.26?ml?h(-1)?kg(-1)), a half-life of 6.8-9.4 days and dose-proportional exposure. Ficlatuzumab/erlotinib had no impact on the PK of either agent. No ADAs were detected. Ficlatuzumab increased serum HGF levels. CONCLUSIONS: Recommended phase II dose is 20?mg?kg(-1) q2w for ficlatuzumab monotherapy or with erlotinib. Preliminary antitumour activity and manageable AEs were observed. Pharmacokinetics were dose-proportional and consistent with other IgG therapeutics. Ficlatuzumab was not immunogenic, and serum HGF was a potential PD marker. Twit Text FOAVip Phase I ficlatuzumab monotherapy or with erlotinib for refractory advanced solid tumours and multiple myeloma ????Br J Cancer http://www.kidney.de/pget.php?&tw=1&pmid=24901237 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=24901237 #FOAvip English Wikipedia <ref>{{Cite pmid|24901237 }}</ref> Phase I ficlatuzumab monotherapy or with erlotinib for refractory advanced solid tumours and multiple myeloma #MMPMID24901237 Patnaik A ; Weiss GJ ; Papadopoulos KP ; Hofmeister CC ; Tibes R ; Tolcher A ; Isaacs R ; Jac J ; Han M ; Payumo FC ; Cotreau MM ; Ramanathan RK Br J Cancer 2014[Jul]; 111 (2 ): 272-80 PMID24901237 show ga BACKGROUND: Ficlatuzumab, a humanised hepatocyte growth factor (HGF) IgG1? inhibitory monoclonal antibody, was evaluated for recommended phase II dose (RP2D), safety, pharmacokinetics (PKs), antidrug antibody (ADA), pharmacodynamics (PDs) and antitumour activity as monotherapy or combined with erlotinib. METHODS: Patients with solid tumours received ficlatuzumab 2, 5, 10 or 20?mg?kg(-1) intravenously every 2 weeks (q2w). Additional patients were treated at the RP2D erlotinib. RESULTS: Forty-one patients enrolled at doses ?20?mg?kg(-1). Common adverse events (AEs) included peripheral oedema, fatigue and nausea. Three patients experienced grade ?3 treatment-related hyperkalaemia/hypokalaemia, diarrhoea or fatigue. Best overall response (44%) was stable disease (SD); median duration was 5.5 months (0.4-18.7 months). One patient has been on therapy with SD for >4 years. Pharmacokinetics of ficlatuzumab showed low clearance (0.17-0.26?ml?h(-1)?kg(-1)), a half-life of 6.8-9.4 days and dose-proportional exposure. Ficlatuzumab/erlotinib had no impact on the PK of either agent. No ADAs were detected. Ficlatuzumab increased serum HGF levels. CONCLUSIONS: Recommended phase II dose is 20?mg?kg(-1) q2w for ficlatuzumab monotherapy or with erlotinib. Preliminary antitumour activity and manageable AEs were observed. Pharmacokinetics were dose-proportional and consistent with other IgG therapeutics. Ficlatuzumab was not immunogenic, and serum HGF was a potential PD marker. |Adult [MESH] |Aged [MESH] |Aged, 80 and over [MESH] |Antibodies, Monoclonal/administration & dosage/adverse effects/pharmacokinetics/*therapeutic use [MESH] |Antineoplastic Combined Chemotherapy Protocols/adverse effects/pharmacokinetics/*therapeutic use [MESH] |Cohort Studies [MESH] |Erlotinib Hydrochloride [MESH] |Female [MESH] |Humans [MESH] |Male [MESH] |Middle Aged [MESH] |Multiple Myeloma/*drug therapy/metabolism/pathology [MESH] |Neoplasms/*drug therapy/metabolism/pathology [MESH] |Protein Kinase Inhibitors/administration & dosage/pharmacokinetics [MESH]Phase I ficlatuzumab monotherapy or with erlotinib for refractory adva(epmc).pdf DeepDyve Pubget Overpricing