A Study of Itacitinib in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Participants With Myelofibrosis

Completed · Phase 2

Conditions studied: MPN (Myeloproliferative Neoplasms)

In brief

The purpose of this study is to evaluate the efficacy and safety of itacitinib combined with low-dose ruxolitinib or itacitinib alone in participants with myelofibrosis (MF).

Key facts

Study ID: NCT03144687
Run by: Incyte Corporation
People needed: 23
Starts: 2018-01-26
Expected to finish: 2021-06-01
Last updated by the study team: 2022-06-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Cohort A only
Receiving ruxolitinib dose of less than 20 mg daily with no dose increase or no dose modification in the last 8 weeks before screening visit.
Cohort B only
Must have had initial reduction in spleen on ruxolitinib treatment:
Followed by documented evidence of progression in spleen length or volume OR
Discontinued ruxolitinib for hematologic toxicities, after the initial reduction in spleen length or volume.
All participants
Confirmed diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis according to revised World Health Organization 2016 criteria.
Must have palpable spleen of greater than or equal to (≥) 5 centimeter (cm) below the left subcostal margin on physical examination at the screening visit.
Eastern Cooperative Oncology Group performance status of 0, 1, or 2.
Screening bone marrow biopsy specimen available or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24.
Life expectancy of at least 24 weeks.
Willingness to avoid pregnancy or fathering children

You may not qualify if…

Lack of recovery from all toxicities from previous therapy (except ruxolitinib) to Grade 1 or better.
Previous treatment with itacitinib or Janus kinase (JAK1) inhibitors (JAK1/JAK2 inhibitor ruxolitinib is permitted).
Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
Recent history of inadequate bone marrow reserve as demonstrated by protocol-defined criteria.
Inadequate liver function at screening and baseline visits as demonstrated by protocol-defined criteria.
Inadequate renal function at screening and baseline visits as demonstrated by protocol-defined criteria.
Active bacterial, fungal, parasitic, or viral infection that requires therapy.
Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection or risk of reactivation: HBV deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) must be undetectable. Participants cannot be positive for hepatitis B surface antigen or anti-hepatitis B core antibodies. Participants who have positive anti-HBs as the only evidence of prior exposure may participate in the study provided that there is both 1) no known history of HBV infection and 2) verified receipt of hepatitis B vaccine.
Known human immunodeficiency virus infection.
Clinically significant or uncontrolled cardiac disease.
Active invasive malignancy over the previous 2 years except treated basal or squamous carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers. Participants with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery may be enrolled as long as they have a reasonable expectation to have been cured with the treatment modality received.
Splenic irradiation within 6 months before receiving the first dose of itacitinib.
Use of any prohibited concomitant medications.
Active alcohol or drug addiction that would interfere with their ability to comply with the study requirements.
Use of any potent/strong cytochrome P450 3A4 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of itacitinib or anticipated during the study.
Use of concomitant treatment of fluconazole at a dose > 200 mg (for ruxolitinib participants treated in Cohort A only).
Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
Currently breastfeeding or pregnant.

Where it is running

Arizona Oncology Associates — Tempe, Arizona, United States
UC Irvine Medical Center — Orange, California, United States
Anschutz Cancer Pavilion - University Of Colorado — Aurora, Colorado, United States
Rocky Mountain Cancer Center — Colorado Springs, Colorado, United States
Rocky Mountain Cancer Center — Denver, Colorado, United States
Norwalk Hospital — Norwalk, Connecticut, United States
Parkview Research Center — Fort Wayne, Indiana, United States
University of Michigan Cancer Center — Ann Arbor, Michigan, United States
Providence Cancer Center — Southfield, Michigan, United States
Nebraska Cancer Specialist — Omaha, Nebraska, United States
University Of New Mexico Cancer Center — Albuquerque, New Mexico, United States
Duke University Medical Center — Durham, North Carolina, United States
Cleveland Clinic — Cleveland, Ohio, United States
Willamette Valley Cancer Institute — Eugene, Oregon, United States
Consultants in Medical Oncology and Hematology, PC — Broomall, Pennsylvania, United States
Texas Oncology - Round Rock Cancer Center — Round Rock, Texas, United States
Texas Oncology San Antonio — San Antonio, Texas, United States
Texas Oncology - Tyler — Tyler, Texas, United States
University of Virginia — Charlottesville, Virginia, United States
Ordensklinikum Linz GmbH, Servicestelle für Studien — Linz, Austria
Paracelsus Medical University Salzburg — Salzburg, Austria
Hanusch Hospital — Vienna, Austria
VU Medical Center — Amsterdam, Netherlands
Maastricht University Medical Center — Maastricht, Netherlands
Erasmus Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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