An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/28/2019 |
Start Date: | April 2012 |
End Date: | January 2020 |
An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)
This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will
evaluate safety and efficacy parameters of itacitinib (INCB039110).
evaluate safety and efficacy parameters of itacitinib (INCB039110).
Inclusion Criteria:
- Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
- Must score at least 1 point on the Dynamic International Prognostic Scoring System
(DIPSS) for prognostic risk factors and have peripheral blast count <10% at both
Screening and Baseline hematology assessments.
- Subjects must discontinue all drugs used to treat underlying MF disease no later than
Day -14.
- Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood
transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC)
>/= 1x10^9/L.
- Subjects must have palpable spleen or history of splenectomy
- Active symptoms at the screening visit
Exclusion Criteria:
- 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 or invasive malignancies over the previous 2
years except treated basal or squamous carcinomas of the skin, completely resected
intraepithelial carcinoma of the cervix and completely resected papillary thyroid and
follicular thyroid cancers.
We found this trial at
15
sites
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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166 Stoneridge Drive
Columbia, South Carolina 29210
Columbia, South Carolina 29210
803-461-3000
South Carolina Oncology Associates, PA South Carolina Oncology Associates (SCOA) is the only comprehensive cancer...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Western Pennsylvania Hospital Featuring 308 private patient beds, West Penn Hospital has served Bloomfield and...
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