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

• Status: Terminated
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Epoetin Alfa; Histone Deacetylase Inhibitors; Panobinostat

Criteria

Key Inclusion Criteria:

• Patients with a lower risk MDS (LOW or INT-1 according to IPSS)

• Red blood cell transfusion dependency of at least 4 Units/8 weeks.

• Not responding to Erythropoietin stimulating agents (ESA) or having a low chance to do so

• Age-adjusted normal cardiac, kidney, liver function

Key Exclusion Criteria:

• Concomitant use of ESA

• Concomitant use of any other investigational drug

• Other malignancy that is not in remission for at least 1 year

• Platelet Count < 75 x 109/L

• Impaired cardiac function or clinically significant cardiac diseases