Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer
Completed · Phase 1
Conditions studied: Tumors
In brief
Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the investigational formulation, is a currently marketed chemotherapeutic agent. The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy. LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability.
Key facts
- Study ID
- NCT00024492
- Run by
- INSYS Therapeutics Inc
- People needed
- 40
- Starts
- 2001-08-01
- Expected to finish
- 2004-06-01
- Last updated by the study team
- 2011-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope National Medical Center — Duarte, California, United States
- 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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