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

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.

• Authors: Mitesh J Borad, Hani M Babiker, Stephen Anthony, Monica Mita, Aby Buchbinder, Taha Keilani, Jean Grem
• Journal: Cancer investigation (Cancer Invest) Vol. 33 Issue 5 Pg. 172-9 (May 2015) ISSN: 1532-4192 [Electronic] England
• PMID: 25844818 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Polyethylene Glycols
• pegaspargase
• Asparaginase
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols
• Asparaginase (administration & dosage, antagonists & inhibitors, pharmacokinetics)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)
• Dose-Response Relationship, Drug
• Female
• Humans
• Lymphoma (drug therapy, pathology)
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Metastasis
• Neoplasms (drug therapy, pathology)
• Polyethylene Glycols (administration & dosage, pharmacokinetics)
• Gemcitabine