Details

Details

Title A Open Label Assessment of Safety and Efficacy of Ruxolitinib (INCB018424) in Subjects with Primary Myelofibrosis, Post Essential. Thrombocythemia - Myelofibrosis and Post Polycythemia Vera - Myelofibrosis who have Platelet Counts of 50 x 10^9 / L to 100 x 10^9 / L

IRB INCT 1Z11

CC CC00175

Hospital Main Campus

Stage N/A

Phase N/A

Disease Hematologic Malignancy, Myelofibrosis

Drug Ruxolitinib

Description

Description

  1. To determine the effects of ruxolitinib on spleen volume and symptomatic burden in patients with primary myelofibrosis (PMF), post polycythemia vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) who have Baseline platelet count of 50 x10^9/L to 100 x 10^9/L.
  2. To determine the safety and tolerability of ruxolitinib in patients with PMF, PPV-MF and PET-MF who have Baseline platelet count of 50 x10^9/L to 100 x109/L.
Inclusion Criteria

Inclusion Criteria

  1. Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy. Must have platelet count between 50 and 100 x109/L at the Screening and/or Baseline visit. Must score at least 1 point on the DIPSS scale for prognostic risk factors, have active symptoms of MF and have peripheral blast count < 5% at both Screening and Baseline laboratory assessments. Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14. Subjects must not have INR > 1.5, or PTT value > 1.5 x ULN. Subjects must have hemoglobin levels at least 6.5 g/dL at Screening, and be willing to accept transfusions to treat low hemoglobin levels.
Exclusion Criteria

Exclusion Criteria

  1. Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant. Subjects with confirmed platelet count < 50 x109/L or ANC < 1 x109/L at the Screening visit. Inadequate liver or renal function, clinically significant concurrent infections requiring therapy, using potent or moderate CYP 3A4 inhibitors at Screening, unstable cardiac function, gastric or esophageal varices, (subjects with a history of an incidental finding of small varices (< 5 mm) may be permitted in the study with Sponsor approval), hemorrhagic strokes, intracranial bleeds or invasive malignancy over the previous 2 years except treated early stage carcinomas of the skin completely resected intraepithelial carcinoma of the cervix and completely resected papillary thyroid and follicular thyroid cancers.