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

This study is currently recruiting participants.

Verified December 2012 by Novartis

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT01034657

First received: December 16, 2009

Last updated: December 3, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 16, 2009

Last Updated Date

December 3, 2012

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Evaluation of the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria (Cheson 2006) in patients treated with LBH589 single agent [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01034657 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Comparison of the hematological improvement of the erythropoietic system (HI-E) using modified IWG criteria (Cheson 2006) in patients treated with either LBH589 single agent or with LBH589 and ESA combination treatment. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Evaluation of the objective response rate (CR + PR and HI-P and HI-N) according to modified IWG criteria (Cheson et al.). [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Determination of the IPSS status as well as the single scoring values of the IPSS for patients at baseline and EOS (end of study). [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Determination of the time to response, event-free survival, progression-free survival (PFS), disease-free survival (DFS), time to cause-specific death, and overall survival (OS) in this patient population. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Evaluation of the safety and tolerability profile of LBH589 and LBH589 + ESA in low and INT-1 risk MDS patients [ Time Frame: up to 48 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This study will assess 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Myelodysplastic Syndrome (MDS)

Intervention ^ICMJE

Drug: oral LBH589/panobinostat
Drug: oral LBH589/panobinostat + Epoitin Alfa HEXAL®

Study Arm (s)

Experimental: LBH589
Intervention: Drug: oral LBH589/panobinostat
Experimental: LBH589 + Epoitin Alfa
Intervention: Drug: oral LBH589/panobinostat + Epoitin Alfa HEXAL®

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

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

Other protocol-defined inclusion/exclusion criteria may apply

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Novartis Pharmaceuticals

+1 800-340-6843

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01034657

Other Study ID Numbers ^ICMJE

CLBH589BDE04, EudraCT 2009-010403-84

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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