Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
Information source: Incyte Corporation
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myelofibrosis
Intervention: Ruxolitinib (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Incyte Corporation Official(s) and/or principal investigator(s): Mark Jones, MD, Study Director, Affiliation: Incyte Corporation
Overall contact: Incyte Corporation Call Center, Phone: 1.855.463.3463
Summary
This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib
in patients with myelofibrosis (MF). Study will consist of 2 phases - dose escalation and
safety expansion. Dose escalation phase will enroll successive cohorts of patients who
receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is
determined. In the safety expansion phase additional patients will be treated with
ruxolitinib at the MSSD defined during dose escalation. The primary objective is to
establish the MSSD of ruxolitinib in patients with MF and starting platelet counts < 100 x
10 ^9/L
Clinical Details
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling.
Secondary outcome: Characterize the safety of ruxolitinib by monitoring the frequency, duration and severity of adverse and serious adverse events.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Require treatment for MF and classified at least as intermediate risk level 1 defined
by the International Working Group.
- Platelet count < 100x10 ^9/L at screening or at Study Day 1.
Exclusion Criteria:
- Received platelet transfusion within 14 days prior to Screening evaluations.
Locations and Contacts
Incyte Corporation Call Center, Phone: 1.855.463.3463
Vienna, Austria; Recruiting
Angers, France; Recruiting
Paris, France; Recruiting
Pierre-Benite, France; Recruiting
Augsburg, Germany; Recruiting
Berlin, Germany; Completed
Leipzig, Germany; Recruiting
Belfast, Ireland; Completed
Firenze, Italy; Recruiting
Milano, Italy; Recruiting
Pavia, Italy; Completed
Terni, Italy; Recruiting
Seoul, Korea, Republic of; Recruiting
Rotterdam, Netherlands; Recruiting
Izmir, Turkey; Not yet recruiting
Belfast, United Kingdom; Completed
London, United Kingdom; Recruiting
Winter Park, Florida 32789, United States; Completed
Baltimore, Maryland 21229, United States; Completed
Houston, Texas 77030, United States; Completed
Additional Information
Starting date: March 2011
Last updated: May 11, 2015
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