Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
Liposome Encapsulated SN38 (LE-SN38) is an oncology drug product consisting of the active
metabolite of irinotecan (CPT-11), a known anticancer drug, encapsulated in a liposome.
Formulation of a relatively insoluble compound (SN38) and improvement in drug delivery
(pharmacodynamic profile) may be obtained with liposomal formulations. An improved safety and
efficacy profile, compared with the pro-drug CPT-11, may be possible. This rationale is
supported by the results from animal toxicity studies in both the mouse and dog.
LE-SN38 will be infused intravenously every 3 weeks to assess safety and tolerability of
study drug until there is disease progression or toxicity requiring early treatment
discontinuation. Disease status will be assessed after every second cycle of treatment. In
the event of disease progression, study treatment will be discontinued, all end-of-treatment
study evaluations will be performed and further treatment options will be reviewed.