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NCT00024492 · ClinicalTrials.gov registry record · Phase 1
Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer
A Phase 1 study of Tumors, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT00024492 is a Phase 1 study of Tumors that has completed, run by INSYS Therapeutics. The registered enrollment target is 40 participants, below the 197-participant average among 20 other Tumors trials with a reported enrollment target (80% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT00024492, a Phase 1 study of Tumors, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Liposome Encapsulated Mitoxantrone (LEM)
Study Locations (4)
California
- City of Hope National Medical Center - Duarte
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-08 |
| Est. Completion | 2004-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00024492
The ClinicalTrials.gov registry entry for NCT00024492 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 197-participant average among 20 other Tumors trials with a reported enrollment target (80% lower). The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Tumors appearing as the primary indexed condition, and to 1 intervention - of which Liposome Encapsulated Mitoxantrone (LEM) is the first listed.
NCT00024492 reports 4 study locations spanning 4 distinct geographic areas - top geographies include California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT00024492 about?
NCT00024492 is a clinical study titled "Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer". 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 lipo...
What is the current status of trial NCT00024492?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2001-08. Estimated completion is 2004-06.
What conditions does trial NCT00024492 study?
This clinical trial studies the following conditions: Tumors.
What interventions are being tested in trial NCT00024492?
The interventions under investigation include: Liposome Encapsulated Mitoxantrone (LEM) (DRUG).
Who is sponsoring clinical trial NCT00024492?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00024492 being conducted?
This trial has 4 study locations across California, Florida, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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