drugset
drugset / Trial / NCT01034657

LBH589 Alone or in Combination With Erythropoietin Stimulating Agents (ESA) in Patients With Low or Int-1 Risk Myelodysplastic Syndromes (MDS)

NCT01034657 ↗

Phase 2 Terminated 34 enrolled Novartis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study assessed the efficacy and safety of LBH589 as single agent and in combination with ESA in red blood cell transfusion-dependent Low and Int-1 MDS patients being either refractory to ESA or with a low probability of response. The study had a non-randomized core phase followed by a randomized phase.

Timeline

Start
2009-11
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Panobinostat Small molecule 30 mg Oral
Subject Panobinostat Small molecule 40 mg Oral
Subject epoetin alfa Protein / enzyme biologic 30000 iu Subcutaneous

Indications

myelodysplastic syndrome