RT Journal Article
SR Electronic
T1 Phase I Trial of Fenretinide Lym-X-Sorb Oral Powder in Adults with Solid Tumors and Lymphomas
JF Anticancer Research
JO Anticancer Res
FD International Institute of Anticancer Research
SP 961
OP 966
VO 31
IS 3
A1 SHIVAANI KUMMAR
A1 MARTIN E. GUTIERREZ
A1 BARRY J. MAURER
A1 C. PATRICK REYNOLDS
A1 MIN KANG
A1 HARDEEP SINGH
A1 SONJA CRANDON
A1 ANTHONY J. MURGO
A1 JAMES H. DOROSHOW
YR 2011
UL http://ar.iiarjournals.org/content/31/3/961.abstract
AB Background: The synthetic retinoid fenretinide (N-(4-hydroxyphenyl)retinamide, 4-HPR) has shown promising anticancer activity in preclinical studies, but its limited oral bioavailability has hindered clinical assessment. 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/m2/day divided into 2 daily doses for 7 days, every 21 days, and 800 mg/m2/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.