To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)

Part of paid clinical trials in New Orleans, Louisiana.

Sponsor
Incyte Corporation
Study ID
NCT04629508
Phase
PHASE2
Status
Completed

Conditions

  • Myelofibrosis
  • Polycythemia Vera
  • Thrombocythemia

Eligibility Criteria

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

Interventions

  • itacitinib — DRUG
    itacitinb Immediate Release (IR) will be dosed orally twice a day

Study Details

This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.

Key Dates

Start date
Jul 12, 2021
Status verified
Aug 2025
Primary completion
Aug 24, 2023
Completion
Aug 24, 2023

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 : Dose Escalation of itacitinib
    Participants will be dosed at different dose levels with a maximum of up to 9 participants per dose level.
  • Experimental: Part 2 : Dose Expansion of itacitinib
    Participants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1.

Primary Outcome Measure

Part 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) [ Time Frame: up to 724 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
Tulane UniversityNew OrleansLouisiana70112-
Rcca Md, LlcBethesdaMaryland20817-
Midamerica Cancer CareKansas CityMissouri64114-
New Jersey Hematology Oncology Associates LlcBrickNew Jersey08724-3009-
Baptist Cancer CenterMemphisTennessee38120-
Vanderbilt UniversityNashvilleTennessee37235-
Texas Oncology - Baylor Sammons Cancer CenterDallasTexas75246-2092-
Renovatio Clinical Consultants LlcSpringTexas77380-

Find similar trials in New Orleans, LA

By research site
Tulane University· New Orleans, LARcca Md, Llc· Bethesda, MDMidamerica Cancer Care· Kansas City, MONew Jersey Hematology Oncology Associates Llc· Brick, NJBaptist Cancer Center· Memphis, TNVanderbilt University· Nashville, TN

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