A phase 1 comparative pharmacokinetic and cardiac safety study of two intravenous formulations of CO-101 in patients with advanced solid tumors

F E Stuurman; M P Lolkema; A D R Huitema; P M M B Soetekouw; H Rosing; L Rolfe; P Kaur; J H Beijnen; H van Tinteren; E E Voest; J H M Schellens

doi:10.1002/jcph.108

A phase 1 comparative pharmacokinetic and cardiac safety study of two intravenous formulations of CO-101 in patients with advanced solid tumors

J Clin Pharmacol. 2013 Aug;53(8):878-83. doi: 10.1002/jcph.108. Epub 2013 Jun 18.

Authors

F E Stuurman¹, M P Lolkema, A D R Huitema, P M M B Soetekouw, H Rosing, L Rolfe, P Kaur, J H Beijnen, H van Tinteren, E E Voest, J H M Schellens

Affiliation

¹ Division of Clinical Pharmacology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. r.stuurman@nki.nl

PMID: 23775853
DOI: 10.1002/jcph.108

No abstract available

Keywords: CO-101; CP-4126; QT/QTc intervals; bioequivalence; cancer; dFdC; dFdU; formulation; gemcitabine; infusion; lipid; phase 1; phospholipids.

Publication types

Clinical Trial, Phase I
Comparative Study
Multicenter Study
Randomized Controlled Trial

MeSH terms

Adult
Aged
Antimetabolites, Antineoplastic / blood
Antimetabolites, Antineoplastic / pharmacokinetics*
Antimetabolites, Antineoplastic / therapeutic use
Cross-Over Studies
Deoxycytidine / analogs & derivatives*
Deoxycytidine / blood
Deoxycytidine / pharmacokinetics
Deoxycytidine / therapeutic use
Female
Heart / drug effects
Heart / physiology
Humans
Male
Middle Aged
Neoplasms / drug therapy
Neoplasms / metabolism
Therapeutic Equivalency
Treatment Outcome

Substances

Antimetabolites, Antineoplastic
CP 4126
Deoxycytidine