title: 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: OBJECTIVE
  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.affiliation: 1Division of Hematology and Oncology, Mayo Clinic , Scottsdale, Arizona , USA.
authors.forename: Mitesh J
authors.initials: MJ
authors.lastname: Borad
authors.forename: Hani M
authors.initials: HM
authors.lastname: Babiker
authors.forename: Stephen
authors.initials: S
authors.lastname: Anthony
authors.forename: Monica
authors.initials: M
authors.lastname: Mita
authors.forename: Aby
authors.initials: A
authors.lastname: Buchbinder
authors.forename: Taha
authors.initials: T
authors.lastname: Keilani
authors.forename: Jean
authors.initials: J
authors.lastname: Grem
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols; D001215:Asparaginase / Q000008:administration & dosage* / Q000037:antagonists & inhibitors / Q000493:pharmacokinetics; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008223:Lymphoma / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000493:pharmacokinetics; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D011092:Polyethylene Glycols; C042705:pegaspargase; D001215:Asparaginase; D000093542:Gemcitabine
keywords: Gemcitabine; Lymphoma; Metastatic solid tumors; Pegaspargase; Phase 1