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Clinical Trial
. 2015 May;33(5):172-9.
doi: 10.3109/07357907.2015.1019677. Epub 2015 Apr 6.

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

Mitesh J Borad  1 , Hani M Babiker, Stephen Anthony, Monica Mita, Aby Buchbinder, Taha Keilani, Jean Grem
Affiliations
Clinical Trial

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

Mitesh J Borad et al. Cancer Invest. 2015 May.

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Keywords: Gemcitabine; Lymphoma; Metastatic solid tumors; Pegaspargase; Phase 1.

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