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NCT01151384 · ClinicalTrials.gov registry record · Phase 1
Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors
A Phase 1 study, sponsored by INSYS Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01151384: Completed Phase 1 study, sponsored by INSYS Therapeutics.
NCT01151384 is a Phase 1 study that has completed, run by INSYS Therapeutics. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151384, a Phase 1 study, has completed, sponsored by INSYS Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects.
Primary Outcome
This Phase I, open-label, dose-escalation study was designed to determine the maximum tolerated dose (MTD) of LE-DT in patients with advanced cancer. LE-DT was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
Interventions
- DRUG LE-DT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-02 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT01151384 record still lists
NCT01151384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which LE-DT is the first listed.
NCT01151384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01151384 about?
NCT01151384 is a clinical study titled "Liposome Encapsulated Docetaxel (LE-DT) in Patients With Solid Tumors". Liposome Encapsulated Docetaxel (LE-DT) is a novel proprietary delivery system of docetaxel developed by NeoPharm, Inc. In this Phase I study, the LE-DT was evaluated for the maximum tolerated dose and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for phar...
What is the current status of trial NCT01151384?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-02. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01151384?
The interventions under investigation include: LE-DT (DRUG).
Who is sponsoring clinical trial NCT01151384?
This trial is sponsored by INSYS Therapeutics, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01151384's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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