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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Incyte Corporation
Study ID
NCT03144687
Phase
PHASE2
Status
Completed

Conditions

  • MPN (Myeloproliferative Neoplasms)

Eligibility Criteria

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

Interventions

  • Itacitinib — DRUG
    Itacitinib self-administered orally once daily .
  • Ruxolitinib — DRUG
    Ruxolitinib self-administered orally at the stable dose of \< 20 mg daily established before entering the study.

Study Details

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 Dates

Start date
Jan 26, 2018
Status verified
May 2022
Primary completion
Mar 14, 2020
Completion
Jun 1, 2021

Study Design

Enrollment
23 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in Spleen Volume at Week 24 Compared to Baseline [ Time Frame: Baseline and Week 24 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Arizona Oncology AssociatesTempeArizona85284-
UC Irvine Medical CenterOrangeCalifornia92868-
Anschutz Cancer Pavilion - University Of ColoradoAuroraColorado80045-
Rocky Mountain Cancer CenterColorado SpringsColorado80907-
Rocky Mountain Cancer CenterDenverColorado80218-
Norwalk HospitalNorwalkConnecticut06856-
Parkview Research CenterFort WayneIndiana46845-
University of Michigan Cancer CenterAnn ArborMichigan48109-
Providence Cancer CenterSouthfieldMichigan48075-
Nebraska Cancer SpecialistOmahaNebraska68124-
University Of New Mexico Cancer CenterAlbuquerqueNew Mexico87102-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
Willamette Valley Cancer InstituteEugeneOregon97401-
Consultants in Medical Oncology and Hematology, PCBroomallPennsylvania19008-
Texas Oncology - Round Rock Cancer CenterRound RockTexas78681-
Texas Oncology San AntonioSan AntonioTexas78240-
Texas Oncology - TylerTylerTexas75702-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in Tempe, AZ

By research site
Arizona Oncology Associates· Tempe, AZUC Irvine Medical Center· Orange, CAAnschutz Cancer Pavilion - University Of Colorado· Aurora, CORocky Mountain Cancer Center· Colorado Springs, CORocky Mountain Cancer Center· Denver, CONorwalk Hospital· Norwalk, CT

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