An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low-Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis

Who is this study for? Patients with myelofibrosis
Status: Completed
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
Arizona
Arizona Oncology Associates
Tempe
California
UC Irvine Medical Center
Orange
Colorado
Anschutz Cancer Pavilion - University Of Colorado
Aurora
Rocky Mountain Cancer Center
Colorado Springs
Rocky Mountain Cancer Center
Denver
Connecticut
Norwalk Hospital
Norwalk
Indiana
Parkview Research Center
Fort Wayne
Michigan
University of Michigan Cancer Center
Ann Arbor
Providence Cancer Center
Southfield
North Carolina
Duke University Medical Center
Durham
Nebraska
Nebraska Cancer Specialist
Omaha
New Mexico
University Of New Mexico Cancer Center
Albuquerque
Ohio
Cleveland Clinic
Cleveland
Oregon
Willamette Valley Cancer Institute
Eugene
Pennsylvania
Consultants in Medical Oncology and Hematology, PC
Broomall
Texas
Texas Oncology - Round Rock Cancer Center
Round Rock
Texas Oncology San Antonio
San Antonio
Texas Oncology - Tyler
Tyler
Virginia
University of Virginia
Charlottesville
Other Locations
Austria
Ordensklinikum Linz GmbH, Servicestelle für Studien
Linz
Paracelsus Medical University Salzburg
Salzburg
Hanusch Hospital
Wien
Netherlands
VU Medical Center
Amsterdam
Maastricht University Medical Center
Maastricht
Erasmus Medical Center
Rotterdam
UMC Utrecht Department of Hematology
Utrecht
Time Frame
Start Date: January 26, 2018
Completion Date: June 1, 2021
Participants
Target number of participants: 23
Treatments
Experimental: Cohort A
Participants with MF who were tolerating a ruxolitinib dose of less than 20 milligrams (mg) daily with no dose increase or no dose modification in the 8 weeks before screening visit received a combination of the itacitinib at the dose of 200 mg, orally, once daily (QD) and ruxolitinib, orally, twice daily (BID) at their previous stable dose (must had been < 20 mg daily). Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
Experimental: Cohort B
Participants with MF who progressed after initial reduction in spleen with ruxolitinib treatment, progressed or discontinued for hematologic toxicities received treatment with itacitinib alone at the dose of 600 mg QD. Participants continued study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or other Protocol-specified criteria to stop treatment are met.
Sponsors
Leads: Incyte Corporation

This content was sourced from clinicaltrials.gov

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