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NCT00046540 · ClinicalTrials.gov registry record · Phase 1
Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer
A Phase 1 study of Neoplasms, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT00046540: Completed Phase 1 study of Neoplasms, sponsored by INSYS Therapeutics.
NCT00046540 is a Phase 1 study of Neoplasms that has completed, run by INSYS Therapeutics. The registered enrollment target is 40 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00046540, a Phase 1 study of Neoplasms, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Liposome-encapsulated SN38
Study Locations (3)
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 | 2002-10 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
What the finished NCT00046540 record still lists
NCT00046540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Liposome-encapsulated SN38 is the first listed.
NCT00046540 reports a single indexed study location in Florida, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT00046540 about?
NCT00046540 is a clinical study titled "Liposome Encapsulated SN38 (LE-SN38) in Patients With Advanced Cancer". 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 ob...
What is the current status of trial NCT00046540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2002-10. Estimated completion is 2010-11.
What conditions does trial NCT00046540 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT00046540?
The interventions under investigation include: Liposome-encapsulated SN38 (DRUG).
Who is sponsoring clinical trial NCT00046540?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00046540 being conducted?
This trial has 3 study locations across Florida, Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00046540's enrollment target sits among peer trials
40 120th of 158 higher than 37 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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