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Study of Ruxolitinib for Patients With Myelofibrosis (MF)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02784496
First received: May 20, 2016
Last updated: March 28, 2017
Last verified: March 2017
  Purpose
The goal of this clinical research study is to collect data about the long term safety and tolerability of ruxolitinib when given to patients with MF.

Condition Intervention Phase
Myelofibrosis Drug: Ruxolitinib Behavioral: Questionnaires Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Open-label Roll-Over Study to Assess the Long-term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Adverse Events in Participants with Myelofibrosis Previously Treated with Ruxolitinib [ Time Frame: 168 days ]
    Severity of adverse events based on the NCI-CTCAE v3.0 (NCI Common Terminology Criteria for Adverse Events


Secondary Outcome Measures:
  • Overall Response in Participants with Myelofibrosis Previously Treated with Ruxolitinib [ Time Frame: 168 days ]
    Overall response assessment graded according to the International Working Group (IWG) consensus criteria for treatment response in primary myelofibrosis (PMF) and post polycythemia vera/essential thrombocythemia myelofibrosis (PV/ET MF).


Enrollment: 8
Actual Study Start Date: September 29, 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ruxolitinib

Participants take ruxolitinib tablets by mouth either 1 or 2 times each day at the same dose and schedule that they were assigned in Study 2007-016. Each study cycle is 28 days.

Questionnaires completed every 6 cycles and at end of study visit.

Drug: Ruxolitinib
Participants take ruxolitinib tablets by mouth either 1 or 2 times each day at the same dose and schedule that they were assigned in Study 2007-016. Each study cycle is 28 days.
Other Names:
  • Jakafi
  • INCB018424
  • INC424
Behavioral: Questionnaires
Questionnaires regarding quality of life completed every 6 cycles and at end of study visit.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Currently enrolled in study 2007-0169 and benefiting from therapy as determined by treating physician,
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment of this study
  3. Ability and agreement to attend protocol-specified visits at the study site
  4. Able to comprehend and willing to sign the informed consent form
  5. Negative pregnancy test in females of childbearing potential. Male patients with female partners of child-bearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Acceptable forms of contraception include 1 highly effective method such as an intrauterine device (IUD), hormonal (birth control pills, injections, or implants), tubal ligation, or partner's vasectomy and at least 1 additional approved barrier method such as a latex condom, diaphragm, or cervical cap. Female patients of childbearing potential must not be breast-feeding or planning to breast feed and must have a negative pregnancy test ≤7 days before first study treatment.

Exclusion Criteria:

1) None

  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: NCT02784496

Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Incyte Corporation
Investigators
Principal Investigator: Srdan Verstovsek, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02784496     History of Changes
Other Study ID Numbers: 2015-0872
NCI-2016-01181 ( Other Identifier: NCI CTRP )
Study First Received: May 20, 2016
Last Updated: March 28, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Myelofibrosis
Primary Myelofibrosis
PMF
Post Polycythemia Vera/Essential Thrombocythemia Myelofibrosis
Post-PV/ET MF
Ruxolitinib
Jakafi
INCB018424
INC424
Questionnaires
Surveys

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

ClinicalTrials.gov processed this record on June 27, 2017