Randomized Open-Label Study of INCB047986 in Subjects With Primary Myelodysplastic Syndrome (MDS)

Stopped early · Phase 1/Phase 2

Conditions studied: MDS (Myelodysplastic Syndrome)

In brief

The study design includes a 3-dose randomization phase to determine effective doses of INCB047986 in patients with myelodysplastic syndrome (MDS) who are refractory or unlikely to respond to erythropoiesis-stimulating agents (ESAs) followed by an extension phase.

Key facts

Study ID

NCT02093429

Run by

Incyte Corporation

People needed

6

Starts

2014-01-01

Expected to finish

2014-09-01

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects 18 years of age or older.
• Subjects must be diagnosed with MDS according to the World Health Organization (WHO) classification for de novo or primary MDS (Vardiman et al 2009).
• Subjects who require RBC transfusions or are either refractory to or unlikely to respond to ESA therapy should meet one of the following criteria:
• ESA failure as defined by no improvement in Hgb of at least 1.5 g/dL after 8 weeks of at least 40,000 IU per week of EPO (or equivalent).
• Have a serum erythropoietin (EPO) of ≥ 500 IU and Hgb level < 10.0 g/dL.
• Transfusion dependence defined as requiring at least 4 units of packed red blood cells (RBCs) for a Hgb of < 9 g/dL over the 8 weeks prior to screening.
• Subjects may not have received hypomethylating agents or immunosuppressive therapy for their MDS prior to this study.

You may not qualify if…

• Subjects at high risk for transformation to acute leukemia as evidenced by poor karyotype or peripheral blood blasts > 10%.
• Subjects with severely compromised bone marrow function as evidenced by trilineage cytopenias with anemia (Hgb < 10 g/L, platelets < 100 × 109/L, and absolute neutrophil count (ANC) < 1.8 × 109/L).
• Subjects who harbor the 5q deletion chromosomal aberration.
• Subjects with chronic myelomonocytic leukemia (CMML).
• Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
• Subjects with impaired liver function, end stage renal disease on dialysis, or clinically significant concurrent infections requiring therapy.
• Subjects with unstable cardiac function.
• Invasive malignancies over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, Stage 1 or 2 treated prostate

Where it is running

• Study site — Highland, California, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Morristown, New Jersey, United States
• Study site — Somerville, New Jersey, United States
• Study site — Germantown, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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