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

NCT01034657 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-08-11

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034657 on ClinicalTrials.gov