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NCT00946647 · ClinicalTrials.gov registry record · Phase 1
A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 113
- Enrollment target
NCT00946647: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT00946647 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 113 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00946647, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 113 participants
- Enrollment target
Study Summary
The purpose of this randomized, two-arm, open-label expansion phase study was to collect preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in combination with azacytidine (5-Aza) versus an active control arm 5-Aza alone. This randomized phase II part also allowed collecting safety data of panobinostat in combination with 5-Aza in comparison to single-agent 5-aza.
Primary Outcome
Dose limiting toxicity (DLT) was defined as a toxicity requiring treatment withdrawal and included the following: Non-hematologic toxicity qualifying for DLT and Hematologic toxicity qualifying for DLT
Interventions
- DRUG Panobinostat (LBH589)
- DRUG 5-Azacytidine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2009-12-02 |
| Est. Completion | 2019-04-29 |
| Phase | Phase 1 |
What the finished NCT00946647 record still lists
NCT00946647 is an interventional study that assigns participants to a tested intervention. The registered 113 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 (88% higher).
The record links to 0 conditions, and to 2 interventions - of which Panobinostat (LBH589) is the first listed.
NCT00946647 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00946647 about?
NCT00946647 is a clinical study titled "A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).". The purpose of this randomized, two-arm, open-label expansion phase study was to collect preliminary efficacy data of panobinostat at the recommended phase II dose (RPIID) level in combination with azacytidine (5-Aza) versus an active control arm 5-Aza alone. This randomized phase II part also allow...
What is the current status of trial NCT00946647?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2009-12-02. Estimated completion is 2019-04-29.
What interventions are being tested in trial NCT00946647?
The interventions under investigation include: Panobinostat (LBH589) (DRUG), 5-Azacytidine (DRUG).
Who is sponsoring clinical trial NCT00946647?
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 NCT00946647's enrollment target sits among peer trials
113 508th of 2000 higher than 1,493 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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