This study is currently not recruiting participants.

A Randomized Open-Label 2-Stage Study of INCB047986 Administered Orally to Subjects With Primary Myelodysplastic Syndrome (MDS) Refractory to or Unlikely to Respond to Erythropoiesis-Stimulating Agents (ESAs)

Investigating the Safety and Tolerability of an Investigational Medication for Myelodysplastic Syndromes (MDS)

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

The purpose of this study is to determine the dose of the study drug INCB047986 that is safe and tolerable when given to subjects that have MDS resistant to, or unlikely to respond to Erthyropoiesis-Stimulating Agents (ESAs). Also to further study the selected dose(s) of the study drug INCB047986 that is safe and tolerable when given in combination with ESAs.

Detailed description of study

The purpose of this study is to determine the dose of the study drug INCB047986 that is safe and tolerable when given to subjects that have MDS resistant to, or unlikely to respond to Erthyropoiesis-Stimulating Agents (ESAs). Also to further study the selected dose(s) of the study drug INCB047986 that is safe and tolerable when given in combination with ESAs.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: myelodysplastic syndrome
  • Age: 18 years - 100 years
  • Gender: All

This study investigates the safety and tolerability of an investigational medication for patients with Myelodysplastic Syndromes (MDS) who are resistant to or unlikely to respond to treatments called Erythropoiesis-Stimulating Agents (ESAs). Myelodysplastic Syndromes are a group of disorders caused by poorly formed or dysfunctional blood cells.

Participants in this study will receive different doses of the investigational medication alone and in combination with ESAs to determine which doses are safe and tolerable. The study will monitor participants for any side effects and how their bodies respond to the treatment.

  • Who can participate: The study is for individuals aged 18 and older with Myelodysplastic Syndromes (MDS) who do not respond well to Erythropoiesis-Stimulating Agents (ESAs).
  • Study details: Participants will receive doses of the investigational medication alone and with ESAs. A placebo may be used, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 19 Feb 2024. Study ID: 1404666903

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