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NCT00550199 · ClinicalTrials.gov registry record · Phase 1
LBH589 and Gemcitabine in the Treatment of Solid Tumors
A Phase 1 study, sponsored by SCRI Development Innovations.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00550199: Clinical Trial Phase 1 study, sponsored by SCRI Development Innovations.
NCT00550199 is a Phase 1 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00550199, a Phase 1 study, was terminated before completion, sponsored by SCRI Development Innovations.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose level. If 1/3 patients experiences dose-limiting toxicity, the dose level will be expanded to 6 patients. If 2/6 patients experience dose-limiting toxicity at a specific dose level, then the previous dose level will be considered the recommended phase II dose. Dose escalation will continue until the maximum tolerated dose is determined or until all dose levels outlined in the protocol have been completed. A total of 10 patients will be treated at the dose that is recommended for further phase II evaluation to further assess the safety of the combination regimen. Toxicity assessments will be ongoing and disease assessments will be repeated every 2 treatment cycles. Patients will be allowed to continue on study until disease progression unless toxicity warrants drug discontinuation.
Interventions
- DRUG LBH589, Gemcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-11 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
Why NCT00550199 stopped before completion
NCT00550199 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 1 intervention - of which LBH589, Gemcitabine is the first listed.
NCT00550199 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00550199 about?
NCT00550199 is a clinical study titled "LBH589 and Gemcitabine in the Treatment of Solid Tumors". This will be a single center phase I dose escalation trial. LBH589 will be administered orally twice weekly. Gemcitabine will be administered intravenously over 30 minutes on days 1, 8, and 15 every 28 days. Dose escalation will begin at Dose Level 1. Three patients will be enrolled at each dose lev...
What is the current status of trial NCT00550199?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-11. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00550199?
The interventions under investigation include: LBH589, Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT00550199?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00550199's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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