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A Study of LDE255 in Combination With Azacitidine for High Risk Myelodysplastic Syndrome Patients

NCT02323139 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-12-06

No results posted yet for this study

Summary

This study is a phase Ib add-on study of the combination of LDE255 to azacitidine in patients without marrow response after at least 6 cycles of azacitidine.

Conditions

Interventions

DRUG

Azacitidine and LDE255

Azacitidine at maximum tolerated dose. LDE255 at dose escalation (200, 400 or 800 mg)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Groupe Francophone des Myelodysplasies

    lead OTHER

Principal Investigators

  • Thomas PREBET, MD · Paoli Calmettes institute

  • Pierre FENAUX, MD, PHD · Saint-Louis Hospital, Paris, France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-10
Primary Completion
2018-01-31
Completion
2018-08-01

Countries

  • France

Study Locations

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Entities

Diseases
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 NCT02323139 on ClinicalTrials.gov