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NCT00621244 · ClinicalTrials.gov registry record · Phase 1
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 175
- Enrollment target
NCT00621244: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00621244 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 175 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00621244, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 175 participants
- Enrollment target
Study Summary
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Primary Outcome
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Interventions
- DRUG LBH589
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2003-03-01 |
| Est. Completion | 2009-12-03 |
| Phase | Phase 1 |
What the finished NCT00621244 record still lists
NCT00621244 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 1 intervention - of which LBH589 is the first listed.
NCT00621244 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00621244 about?
NCT00621244 is a clinical study titled "A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies". This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
What is the current status of trial NCT00621244?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 175 participants. The study started on 2003-03-01. Estimated completion is 2009-12-03.
What interventions are being tested in trial NCT00621244?
The interventions under investigation include: LBH589 (DRUG).
Who is sponsoring clinical trial NCT00621244?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00621244's enrollment target sits among peer trials
175 319th of 2000 higher than 1,679 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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