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Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia

NCT01286038 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2022-11-07

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people who have myelodysplastic syndrome (MDS) with thrombocytopenia who have progressed or are resistant to decitabine or azacitidine. (These are the only 2 drugs approved by the U.S. Food and Drug Administration \[FDA\] which can improve platelet counts). The investigators (the study doctor, study staff, and sponsor) want to find out what effects, good or bad, eltrombopag (study drug) may have on people with low platelet counts due to MDS. The investigators will also be testing how well eltrombopag may work at different doses in these diseases.

Conditions

Interventions

DRUG

Eltrombopag

In Stage 1 the best dose of eltrombopag will be found to take into Stage 2, which will treat 15 participants at this dose.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Rami Komrokji, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-06
Primary Completion
2017-11-03
Completion
2018-11-03

Countries

  • United States

Study Locations

More Related Trials

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 NCT01286038 on ClinicalTrials.gov