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



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:5/10/2018
Start Date:July 31, 2017
End Date:March 2019
Contact:Incyte Corporation Call Center (US)
Email:medinfo@incyte.com
Phone:1.855.463.3463

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

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


Inclusion Criteria:

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 subjects

- 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 ≥ 5 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

Exclusion Criteria:

- Lack of recovery from all toxicities from previous therapy (except ruxolitinib) to
Grade 1 or better.

- Previous treatment with itacitinib or 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 DNA and HCV RNA must be undetectable. Subjects cannot be positive
for hepatitis B surface antigen or anti-hepatitis B core antibodies. Subjects 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. Subjects
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 cytochrome P450 3A4 inhibitors or inducers 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
subjects treated in Cohort A only).

- Inadequate recovery from toxicity and/or complications from a major surgery before
starting therapy.

- Currently breastfeeding or pregnant.
We found this trial at
19
sites
Tyler, Texas 75702
Principal Investigator: Habte Yimer
Phone: 903-579-9800
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Arana Yi
Phone: 505-925-0379
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Aaron Gerds, MD
Phone: 216-444-9464
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Principal Investigator: Karen Seiter
Phone: 914-493-8375
New York Medical College The College was founded in 1860 by a group of New...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
Principal Investigator: Moshe Talpaz, MD
Phone: 734-936-3879
University of Michigan Health System The University of Michigan is home to one of the...
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Aurora, Colorado 80045
Principal Investigator: Brandon McMahon
Phone: 720-848-2587
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Duong
Phone: 410-328-6635
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Michael Keng, MD
Phone: 434-982-3927
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Detroit, Michigan 48201
Principal Investigator: Jay Yang
Phone: 313-576-9758
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Murat Arcasoy
Phone: 919-681-4769
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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520 Country Club Road
Eugene, Oregon 97401
Principal Investigator: Jeff Sharman, MD
Phone: 281-863-4631
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Fort Wayne, Indiana 46805
Principal Investigator: Robert Manges
Phone: 260-425-6831
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428 East 72nd Street
New York, New York 10021
Principal Investigator: Ellen Ritchie
Phone: 212-746-2389
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Norwalk, Connecticut 06856
Principal Investigator: Richard Frank
Phone: 203-852-2996
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Orange, California 92868
Principal Investigator: Angela Fleischman, MD
Phone: 714-456-5408
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2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
Principal Investigator: Roger Lyons
Phone: 210-595-5680
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Southfield, Michigan 48075
Principal Investigator: Howard Terebelo
Phone: 248-849-5332
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Tempe, Arizona 85284
Principal Investigator: Kasra Karamlou
Phone: 480-256-1664
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 444-2000
Principal Investigator: Craig Kessler
Phone: 202-687-0116
Georgetown University Hospital MedStar Georgetown University Hospital is a not-for-profit, acute-care teaching and research hospital...
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