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Study of Azacitidine With or Without Birinapant in Subjects With MDS or CMMoL

NCT02147873 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2016-10-20

No results posted yet for this study

Summary

This is a randomized double blind placebo controlled study of azacitidine with or without birinapant in subjects with higher risk Myelodysplastic syndrome, secondary MDS or myelomonocytic leukemia (CMMoL) who are naïve, to azacitidine therapy. Pre-clinical and mechanistic studies support that azacitidine may modulate pathways that enable birinapant-mediated anti-tumor activity.

Conditions

  • Myelodysplastic Syndrome (MDS)
  • Chronic Myelomonocytic Leukemia (CMML)

Interventions

DRUG

birinapant

DRUG

Azacitidine

DRUG

Placebo

Sponsors & Collaborators

  • TetraLogic Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-01-31
Completion
2016-06-30

Countries

  • United States
  • Australia
  • Germany
  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT02147873 on ClinicalTrials.gov