Study:
A Phase Ib/IIb, Open-label, Multi-center, Study of Oral Panobinostat (LBH589) Administered With 5-Azacitidine (in Adult Patients With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).
Rationale:
n/a
Purpose:
The purpose of this randomized, two-arm, open-label expansion phase study is 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 allows also collecting safety data of panobinostat in combination
with 5-Aza in comparison to single-agent 5-aza.
Study Status: Recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Acute Myeloid Leukemia |
Drug: Panobinostat (LBH589) and 5-Azacytidine
Drug: 5-Azacytidine |
Phase 2 |
Verified by
Novartis Pharmaceuticals
May, 2013
Sponsored by: Novartis Pharmaceuticals
Information provided by: Novartis
ClinicalTrials.gov identifier: NCT00946647
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation Cleve Clinic
Cleveland, Ohio 44195
United States
Novartis Pharmaceuticals., Study Director