Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer
Completed · Phase 1
Conditions studied: Neoplasms
In brief
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.
Key facts
- Study ID
- NCT00046540
- Run by
- INSYS Therapeutics Inc
- People needed
- 40
- Starts
- 2002-10-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2011-07-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
- The Ohio State University — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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