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; Hani M. Babiker; Stephen Anthony; Monica Mita; Aby Buchbinder; Taha Keilani; Jean Grem

doi:10.3109/07357907.2015.1019677

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, Hani M. Babiker, Stephen Anthony, Monica Mita, Aby Buchbinder, Taha Keilani, Jean Grem

Hematology/Oncology

Research output: Contribution to journal › Article › peer-review

3 Scopus citations

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.

Original language	English (US)
Pages (from-to)	172-179
Number of pages	8
Journal	Cancer Investigation
Volume	33
Issue number	5
DOIs	https://doi.org/10.3109/07357907.2015.1019677
State	Published - May 28 2015

Keywords

Gemcitabine
Lymphoma
Metastatic solid tumors
Pegaspargase
Phase 1

ASJC Scopus subject areas

Oncology
Cancer Research

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10.3109/07357907.2015.1019677

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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. / Borad, Mitesh J.; Babiker, Hani M.; Anthony, Stephen et al.
In: Cancer Investigation, Vol. 33, No. 5, 28.05.2015, p. 172-179.

Research output: Contribution to journal › Article › peer-review

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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.",

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AU - Anthony, Stephen

AU - Mita, Monica

AU - Buchbinder, Aby

AU - Keilani, Taha

AU - Grem, Jean

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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

Abstract

Keywords

ASJC Scopus subject areas

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