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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

Page last updated: August 23, 2015

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