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Spots Global Cancer Trial Database for Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia

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Trial Identification

Brief Title: Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia

Official Title: A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia Who Progressed or Are Resistant to Hypomethylating Agents

Study ID: NCT01286038

Interventions

Eltrombopag

Study Description

Brief 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.

Detailed Description: Study was originally designed as a Phase I/II but was terminated during the Phase I portion due to lack of efficacy

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Contact Details

Name: Rami Komrokji, M.D.

Affiliation: H. Lee Moffitt Cancer Center and Research Institute

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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