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Study of Ruxolitinib for Patients With Myelofibrosis (MF)

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ClinicalTrials.gov Identifier: NCT02784496
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Incyte Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Myelofibrosis Drug: Ruxolitinib Behavioral: Questionnaires Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Roll-Over Study to Assess the Long-term Safety and Efficacy of Ruxolitinib in Subjects With Myelofibrosis
Actual Study Start Date : September 29, 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Prithviraj Bose, MD M.D. Anderson Cancer Center

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 )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

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