biostudies-literatureHingorani SRNCI NIH HHS2848-54https://www.ebi.ac.uk/biostudies/studies/S-EPMC7787348biostudies-literatureUnknown22(12)<h4>Purpose</h4>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.<h4>Experimental design</h4>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 administerClinical cancer research : an official journal of the American Association for Cancer ResearchPhase Ib Study of PEGylated Recombinant Human Hyaluronidase and Gemcitabine in Patients with Advanced Pancreatic Cancer.PMC7787348P30 CA076292Beck JTHingorani SRHarris WPRaghunand NGladkov OAJiang PHolcombe RFDychter SPshevlotsky EMTjulandin SAShepard HMBerdov BADevoe CEWagner SAKorn RfalsePhase Ib Study of PEGylated Recombinant Human Hyaluronidase and Gemcitabine in Patients with Advanced Pancreatic Cancer.<h4>Purpose</h4>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.<h4>Experimental design</h4>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 administer2016-01-01T00:00:00Z2016 Jun2026-05-02T06:35:56.598Z2025-04-04T07:16:19.408ZS-EPMC77873482681335910.1158/1078-0432.CCR-15-201010.1158/1078-0432.ccr-15-2010