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dc.contributor.authorDe Boer, R Hen
dc.contributor.authorRoskos, L Ken
dc.contributor.authorCheung, Een
dc.contributor.authorFox, Sen
dc.contributor.authorBasser, R Len
dc.contributor.authorMarty, Jen
dc.contributor.authorBegley, C Gen
dc.contributor.authorCebon, Jonathan Sen
dc.identifier.citationGrowth Factors (chur, Switzerland); 18(3): 215-26en
dc.description.abstractPhase I studies with pegylated megakaryocyte growth and development factor (PEG-rHuMGDF), a c-Mpl ligand that stimulates megakaryopoiesis, have demonstrated that PEG-rHuMGDF is biologically active alone and causes a dose-related enhancement of platelet recovery when administered after chemotherapy. Here we report the dose-ranging pharmacokinetics of PEG-rHuMGDF. Pre-injection blood samples were drawn daily for pharmacokinetic studies on 43 patients. An ELISA, established using PEG-rHuMGDF as the standard, was able to quantitate Mpl ligand at concentrations > 0.02 ng/mL. Over the dose range 0.03 to 5.0 microg/kg/day, subcutaneous administration produced linear increases in steady-state serum levels. Maximum levels of PEG-rHuMGDF attained after 5.0 microg/kg/day were 5.88 to 10.9 ng/mL. After discontinuation of PEG-rHuMGDF, concentrations of Mpl ligand returned to baseline within 5 days. The pharmacokinetics were best described by a one-compartment model with first-order absorption, an absorption delay, and non linear clearance over the first 48 hours. The mean terminal half-life was 33.3 + 16.7 hours, and the average apparent at steady state was 27.7 + 14.0 mL/h/kg; both were independent of administered dose. The apparent clearance of PEG-rHuMGDF was not predicted by platelet count. Administration of chemotherapy and Filgrastim did not alter the pharmacokinetics of PEG-rHuMGDF.en
dc.subject.otherAntineoplastic Agents.administration & dosageen
dc.subject.otherDose-Response Relationship, Drugen
dc.subject.otherDrug Administration Scheduleen
dc.subject.otherEnzyme-Linked Immunosorbent Assay.methodsen
dc.subject.otherInjections, Subcutaneousen
dc.subject.otherNeoplasms.blood.drug therapyen
dc.subject.otherPlatelet Counten
dc.subject.otherPolyethylene Glycols.administration & dosage.pharmacokineticsen
dc.subject.otherRecombinant Proteins.administration & dosage.blood.pharmacokineticsen
dc.subject.otherThrombopoietin.administration & dosage.blood.pharmacokineticsen
dc.titlePharmacokinetic analysis of pegylated megakaryocyte growth and development factor in humans.en
dc.typeJournal Articleen
dc.identifier.journaltitleGrowth factors (Chur, Switzerland)en
dc.identifier.affiliationLudwig Institute Oncology Unit, Austin Repatriation Medical Centre, Australiaen
dc.type.austinJournal Articleen
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
item.cerifentitytypePublications- Newton-John Cancer Research Institute-
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