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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 is a Phase 1 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 17 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00550199
The ClinicalTrials.gov registry entry for NCT00550199 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LBH589, Gemcitabine is the first listed.
NCT00550199 reports 0 study locations.
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.
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