An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT01633372
Phase
PHASE2
Status
Completed

Conditions

  • MPN (Myeloproliferative Neoplasms)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).

Key Dates

Start date
Jul 16, 2012
Status verified
Aug 2021
Primary completion
Dec 31, 2013
Completion
Jun 29, 2021

Study Design

Enrollment
87 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: itacitinib 100 mg
    itacitinib 100 mg twice a day
  • Experimental: itacitinib 200 mg
    itacitinib 200 mg twice a day
  • Experimental: itacitinib 300 mg
    itacitinib 300 mg once a day
  • Experimental: itacitinib 400 mg
    itacitinib 400 mg once a day
  • Experimental: itacitinib 600 mg
    itacitinib 600 mg once a day

Primary Outcome Measure

Proportion of subjects with >/= 50% reduction in total symptom score in each dose group, as measured by the modified The Myelofibrosis Symptom Assessment Form (MFSAF) v3.0 diary [ Time Frame: Baseline and Week 12 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Birmingham Hematology Oncology Associates, LLCBirminghamAlabama--
Mayo Clinic, ArizonaScottsdaleArizona--
UCLA Hematology & OncologyLos AngelesCalifornia--
Emory UniversityAtlantaGeorgia--
St Agnes HospitalBaltimoreMaryland--
University of Michigan Cancer CenterAnn ArborMichigan--
Mount Sinai School of MedicineNew YorkNew York--
Oregon Health & Science UniversityPortlandOregon--
University of Pennsylvania Health SystemPhiladelphiaPennsylvania--
Western Pennsylvania HospitalPittsburghPennsylvania--
South Carolina Oncology & AssociatesColumbiaSouth Carolina--
Boston Baskin Cancer Foundation, Inc.MemphisTennessee--
Tennessee OncologyNashvilleTennessee--
MD Anderson Cancer CenterHoustonTexas--

Find similar trials in Birmingham, AL

By research site
Birmingham Hematology Oncology Associates, LLC· Birmingham, ALMayo Clinic, Arizona· Scottsdale, AZUCLA Hematology & Oncology· Los Angeles, CAEmory University· Atlanta, GASt Agnes Hospital· Baltimore, MDUniversity of Michigan Cancer Center· Ann Arbor, MI

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