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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Incyte Corporation
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01317875
First received: March 14, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Myelofibrosis
Drug: Ruxolitinib
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • To establish the MSSD of ruxolitinib in patients with MF and baseline platelet counts < 100,000 as measured through blood sampling. [ Time Frame: Measured at the completion of each consecutive dose cohort using a Bayesian logistic regression model. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the safety of ruxolitinib by monitoring the frequency, duration and severity of adverse and serious adverse events. [ Time Frame: Baseline, weekly for the 1st month of the study and then every 2 weeks until study completion or early termination at week 156. In addition, safety will also be assessed through the spontaneous reporting of serious adverse events. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 62
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib Drug: Ruxolitinib

Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg BID

Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317875

Contacts
Contact: Incyte Corporation Call Center 1.855.463.3463

Locations
United States, Florida
Completed
Winter Park, Florida, United States, 32789
United States, Maryland
Completed
Baltimore, Maryland, United States, 21229
United States, Texas
Completed
Houston, Texas, United States, 77030
Austria
Recruiting
Vienna, Austria
France
Recruiting
Angers, France
Recruiting
Paris, France
Recruiting
Pierre-Benite, France
Germany
Completed
Berlin, Germany
Recruiting
Leipzig, Germany
Ireland
Recruiting
Belfast, Ireland
Italy
Recruiting
Firenze, Italy
Recruiting
Milano, Italy
Completed
Pavia, Italy
Korea, Republic of
Not yet recruiting
Seoul, Korea, Republic of
Netherlands
Recruiting
Rotterdam, Netherlands
Turkey
Not yet recruiting
Izmir, Turkey
United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Incyte Corporation
Novartis
Investigators
Study Director: Lance Leopold, MD Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01317875     History of Changes
Other Study ID Numbers: CINC424A2201
Study First Received: March 14, 2011
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Primary Myelofibrosis
Thrombocythemia, Essential
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Blood Coagulation Disorders
Thrombocytosis
Blood Platelet Disorders
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on July 22, 2014