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NCT00100139 · ClinicalTrials.gov registry record · Phase 1
Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT00100139 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 48 participants.
The verdict
NCT00100139, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this study, each patient will receive one intravenous infusion of LEP-ETU or Taxol, followed 3 weeks later by an infusion of the other drug, at the same dose and infusion duration. Multiple blood samples will be taken for analysis before, during, and after both drug infusions. Upon completing these 2 Cycles of treatment, eligible patients may enroll in an extension study (LEP-ETU-102B) to continue treatment with LEP-ETU. LEP-ETU is a liposomal formulation of paclitaxel, a widely used anti-cancer drug. This LEP-ETU formulation of paclitaxel is being developed to potentially reduce toxicities associated with Taxol, by eliminating the drug formulation component polyoxyethylated castor oil (Cremophor® EL). In LEP-ETU, paclitaxel is associated with liposomes, which are microscopic membrane-like structures created from lipids (fats). Thus, the LEP-ETU formulation could potentially have reduced toxicity, while maintaining or enhancing efficacy.
Interventions
- DRUG Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU)
- DRUG Paclitaxel for injection (Taxol)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2004-11 |
| Est. Completion | 2010-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00100139
The ClinicalTrials.gov registry entry for NCT00100139 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is INSYS Therapeutics, which has 35 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is the first listed.
NCT00100139 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00100139 about?
NCT00100139 is a clinical study titled "Comparison of Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) and Taxol® Pharmacokinetics in Patients With Advanced Cancer". In this study, Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) is being compared to Taxol® to examine whether the paclitaxel in these 2 formulations undergoes similar processing by the body. Safety and tolerability of LEP-ETU and Taxol will also be assessed. In this study, each patient will rece...
What is the current status of trial NCT00100139?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2004-11. Estimated completion is 2010-06.
What interventions are being tested in trial NCT00100139?
The interventions under investigation include: Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) (DRUG), Paclitaxel for injection (Taxol) (DRUG).
Who is sponsoring clinical trial NCT00100139?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
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