A Phase 1/2 , Open-Label Study of the JAK2 Inhibitor INCB018424 Administered Orally to Patients With Primary Myelofibrosis (PMF) and Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis (Post-PV/ET)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events (AEs)

Outcome Description:

Treatment-Emergent AEs are events occurring after first drug administration or worsened from baseline. Treatment-Related AEs are those with a definite, probable, possible or missing causality. A serious AE is a medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a medical event requiring intervention to prevent 1 of the above. A severe or life-threatening AE is based on intensity, according to NCI-CTCAE v3.0.

Outcome Time Frame:

From Baseline to the interim clinical cut-off date (31 December 2009). The median time on study was 14.8 months, with a range of 26 days to 29.7 months. As of March 1, 2011 the total exposure to ruxolitinib was 269 patient-years.

Safety Issue:

Yes

Principal Investigator

Srdan Verstovsek, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center, Houston, TX

Authority:

United States: Food and Drug Administration

Study ID:

INCB 18424-251

NCT ID:

NCT00509899

Start Date:

June 2007

Completion Date:

April 2015

Related Keywords:

• Myelofibrosis
• Polycythemia Vera
• Thrombocytosis
• Primary Myelofibrosis
• Polycythemia
• Polycythemia Vera
• Thrombocythemia, Essential
• Thrombocytosis