{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Hingorani SR"],"funding":["NCI NIH HHS"],"pagination":["2848-54"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7787348"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["22(12)"],"pubmed_abstract":["Purpose
This phase Ib study evaluated the safety and tolerability of PEGylated human recombinant hyaluronidase (PEGPH20) in combination with gemcitabine (Gem), and established a phase II dose for patients with untreated stage IV metastatic pancreatic ductal adenocarcinoma (PDA). Objective response rate and treatment efficacy using biomarker and imaging measurements were also evaluated.Experimental design
Patients received escalating intravenous doses of PEGPH20 in combination with Gem using a standard 3+3 dose-escalation design. In cycle 1 (8 weeks), PEGPH20 was administrated twice weekly for 4 weeks, then once weekly for 3 weeks; Gem was administrated once weekly for 7 weeks, followed by 1 week off treatment. In each subsequent 4-week cycle, PEGPH20 and Gem were administer"],"journal":["Clinical cancer research : an official journal of the American Association for Cancer Research"],"pubmed_title":["Phase Ib Study of PEGylated Recombinant Human Hyaluronidase and Gemcitabine in Patients with Advanced Pancreatic Cancer."],"pmcid":["PMC7787348"],"funding_grant_id":["P30 CA076292"],"pubmed_authors":["Beck JT","Hingorani SR","Harris WP","Raghunand N","Gladkov OA","Jiang P","Holcombe RF","Dychter S","Pshevlotsky EM","Tjulandin SA","Shepard HM","Berdov BA","Devoe CE","Wagner SA","Korn R"],"additional_accession":[]},"is_claimable":false,"name":"Phase Ib Study of PEGylated Recombinant Human Hyaluronidase and Gemcitabine in Patients with Advanced Pancreatic Cancer.","description":"Purpose
This phase Ib study evaluated the safety and tolerability of PEGylated human recombinant hyaluronidase (PEGPH20) in combination with gemcitabine (Gem), and established a phase II dose for patients with untreated stage IV metastatic pancreatic ductal adenocarcinoma (PDA). Objective response rate and treatment efficacy using biomarker and imaging measurements were also evaluated.Experimental design
Patients received escalating intravenous doses of PEGPH20 in combination with Gem using a standard 3+3 dose-escalation design. In cycle 1 (8 weeks), PEGPH20 was administrated twice weekly for 4 weeks, then once weekly for 3 weeks; Gem was administrated once weekly for 7 weeks, followed by 1 week off treatment. In each subsequent 4-week cycle, PEGPH20 and Gem were administer","dates":{"release":"2016-01-01T00:00:00Z","publication":"2016 Jun","modification":"2026-05-02T06:35:56.598Z","creation":"2025-04-04T07:16:19.408Z"},"accession":"S-EPMC7787348","cross_references":{"pubmed":["26813359"],"doi":["10.1158/1078-0432.CCR-15-2010","10.1158/1078-0432.ccr-15-2010"]}}