A Multicenter, Open-Label, Phase 1 Study Evaluating the Safety and Tolerability of Pegaspargase in Combination with Gemcitabine in Advanced Metastatic Solid Tumors and Lymphoma. (28th May 2015)

• Record Type: Journal Article
• Authors: Borad, Mitesh J.; Babiker, Hani M.; Anthony, Stephen; Mita, Monica; Buchbinder, Aby; Keilani, Taha; Grem, Jean
• Is Part Of: Cancer investigation. Volume 33:Number 5(2015)
• Page Start: 172
• Page End: 179
• Publication Date: 2015-05-28
• Subjects: Cancer -- Periodicals; Oncology -- Periodicals; Medical Oncology -- Periodicals; Neoplasms -- Periodicals; 616.994
• DOI: 10.3109/07357907.2015.1019677
• Languages: English
• ISSNs: 0735-7907

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <p> <italic>Purpose:</italic> To evaluate the maximum tolerated dose, safety profile, pharmacokinetics, and pharmacodynamics of pegaspargase (PEG-ASP) in combination with gemcitabine in patients with advanced metastatic solid tumors and lymphoma. <italic>Methods: </italic> We conducted a multicenter, open label, nonrandomized, Phase 1 dose escalation study designed to evaluate up to 10 cohorts of patients with advanced or metastatic solid tumors and lymphoma. Seventeen patients were treated with of PEG-ASP in combination with gemcitabine. <italic>Results:</italic> The study was terminated early because the doses for PEG-ASP suggested for de-escalation were predicted not to provide desired sustained asparaginase concentrations based on the analysis of treated patients.</p> </abstract>