ABSTRACT
BACKGROUND:
The synthetic retinoid fenretinide (N-(4-hydroxyphenyl)retinamide, 4-HPR)A novel lipid matrix, Lym-X-Sorb (LXS), was evaluated to improve fenretinide bioavailability and attain higher plasma concentrations.
PATIENTS AND METHODS:
Adults with refractory malignancies were administered fenretinide/LXS oral powder in 2 divided doses over 24 h for 7 consecutive days every 21 days in a standard phase I dose-escalation study with pharmacokinetic analysis.
RESULTS:
The principal toxicities observed were diarrhea, reversible night blindness, and allergic reaction. The maximum tolerated dose regimens were 1,000 mg/m(2)/day divided into 2 daily doses for 7 days, every 21 days, and 800 mg/m(2)/day divided into 3 daily doses for 7 consecutive days, every 21 days.
CONCLUSION:
Better fenretinide formulations are needed to improve adult patient acceptability and compliance and to achieve the consistent systemic exposures associated with activity in preclinical models.
Phase I trial of fenretinide lym-x-sorb oral powder in adults with solid tumors and lymphomas
Riferimento:
Anticancer Res. 2011 Mar;31(3):961-6.
Autori:
Kummar S, Gutierrez ME, Maurer BJ, Reynolds CP, Kang M, Singh H, Crandon S, Murgo AJ, Doroshow JH.
Fonte:
Anticancer Res. 2011 Mar;31(3):961-6.
Anno:
2011
Azione:
Biodisponibilità e accettabilità della fenretinide (4-HPR) nel paziente adulto con neoplasie refrattarie.
Target:
Fenretinide (4-HPR)/neoplasie refrattarie.
Sostanze: