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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01317875
First received: March 14, 2011
Last updated: June 1, 2017
Last verified: June 2017
  Purpose
This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The 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

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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. ]

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. ]

Enrollment: 69
Study Start Date: March 2011
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (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 twice a day (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Florida
Winter Park, Florida, United States, 32789
United States, Maryland
Baltimore, Maryland, United States, 21229
United States, Texas
Houston, Texas, United States, 77030
Austria
Vienna, Austria
China, Jiangsu
Nanjing, Jiangsu, China
China, Sichuan
Chengdu, Sichuan, China
China, Zhejiang
Hangzhou, Zhejiang, China
China
Beijing, China
France
Angers, France
Paris, France
Pierre-Benite, France
Germany
Leipzig, Germany
Italy
Firenze, Italy
Milano, Italy
Terni, Italy
Netherlands
Rotterdam, Netherlands
United Kingdom
Belfast, United Kingdom
London, United Kingdom
Sponsors and Collaborators
Incyte Corporation
Novartis
Investigators
Study Director: Mark Jones, MD Incyte Corporation
  More Information

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01317875     History of Changes
Other Study ID Numbers: CINC424A2201
Study First Received: March 14, 2011
Last Updated: June 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on July 21, 2017