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 L Grem

Research output: Contribution to journalArticle

2 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)172-179
Number of pages8
JournalCancer Investigation
Volume33
Issue number5
DOIs
StatePublished - May 28 2015

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gemcitabine
Lymphoma
Safety
Neoplasms
Asparaginase
Maximum Tolerated Dose
Pharmacokinetics
pegaspargase

Keywords

  • Gemcitabine
  • Lymphoma
  • Metastatic solid tumors
  • Pegaspargase
  • Phase 1

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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; Mita, Monica; Buchbinder, Aby; Keilani, Taha; Grem, Jean L.

In: Cancer Investigation, Vol. 33, No. 5, 28.05.2015, p. 172-179.

Research output: Contribution to journalArticle

Borad, Mitesh J. ; Babiker, Hani M. ; Anthony, Stephen ; Mita, Monica ; Buchbinder, Aby ; Keilani, Taha ; Grem, Jean L. / 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. In: Cancer Investigation. 2015 ; Vol. 33, No. 5. pp. 172-179.
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