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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 113 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00946647
The ClinicalTrials.gov registry entry for NCT00946647 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Panobinostat (LBH589) is the first listed.
NCT00946647 reports 0 study locations.
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.
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