CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
Panobinostat (LBH589) +1 moredrug
Likely dose
Panobinostat (LBH589) 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00946647
NCT00946647Phase 2Completed
CompareCT.gov

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).

Novartis Pharmaceuticals·interventional·Posted Jul 27, 2009·Updated Aug 4, 2020

In Brief

A Phase 2 clinical trial evaluating Panobinostat (LBH589) and 5-Azacytidine for Myelodysplastic Syndromes and 2 related conditions. Completed, enrolled 113 participants across 38 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, Acute Myeloid Leukemia
CountriesAustria, Belgium, Canada, France, Germany, Hungary, Italy, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 27, 2009
Enrollment StartDec 2, 2009
Primary CompletionApr 29, 2019
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 16.9 years ago

Interventions

Panobinostat (LBH589)drug

Panobinostat was supplied by Novartis as immediate-release hard gelatin capsules in strengths of 5 mg, 10 mg, and 20 mg packaged in high density polyethylene bottles.

5-Azacytidinedrug