NCT01034657

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

A One Year, Open Label, Multicenter Trial of LBH589 Alone or 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 GErman PAnobinostat Low Risk MDS Trial - GEPARD Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndrome (MDS)

Interventions

Type	Name	Description
DRUG	LBH589	LBH589 was supplied at dose strengths of 5 mg or 20 mg hard gelatin capsules.
DRUG	Epoetin Alfa	Epoetin alfa was supplied as 10000 IU/1 mL in a ready-to-use syringe.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2009-12-17
• Last updated: 2017-08-11
• Results posted: 2017-01-25

Locations

12 sites across 1 country: Germany