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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)

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ClinicalTrials.gov Identifier: NCT04629508
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelofibrosis Polycythemia Vera Thrombocythemia Drug: itacitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : July 29, 2024


Arm Intervention/treatment
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.
Drug: itacitinib
itacitinb Immediate Release (IR) will be dosed orally twice a day
Other Name: INCB039110

Experimental: Part 2 : Dose Expansion of itacitinib
Participants will be dosed at the recommended Phase 2 dose (RP2D) identified in Part 1.
Drug: itacitinib
itacitinb Immediate Release (IR) will be dosed orally twice a day
Other Name: INCB039110




Primary Outcome Measures :
  1. Part 1 : Treatment Emergent Adverse Events (TEAE'S) [ Time Frame: 24 Weeks ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.

  2. Part 2 : Spleen Volume Reduction by MRI/CT Scan [ Time Frame: 24 weeks ]
    Defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35 percent when compared with baseline.

  3. Part 2 : Spleen Volume Reduction [ Time Frame: 24 weeks ]
    Defined as the proportion of participants who have a reduction in spleen volume (by imaging) of at least 35% when compared with baseline.


Secondary Outcome Measures :
  1. Part 2 : Treatment Emergent Adverse Events (TEAE'S) [ Time Frame: 13 months ]
    Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study treatment up to 30 days after last dose of study treatment.

  2. Part 2 : Improvement in Total Symptom Score (TSS) [ Time Frame: 24 Weeks ]
    Defined as the proportion of participants who achieve at least 50% reduction in TSS over the 28 days immediately before the end of Week 24 compared with the 7 days immediately before the initiation of itacitinib IR (baseline).

  3. Part 2 : Improvement in quality of life. [ Time Frame: 24 weeks ]
    Defined as the mean change in the 5 multi-item functional scale scores and the multi-item global health status scale score (EORTC QLQ-C30).

  4. Part 2 : Improvement in Patient Global Impression of Change (PGIC) [ Time Frame: 24 Weeks ]
    Defined as percentage of participants who are categorized as improved



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
  • At least Intermediate 1 risk MF according to the DIPSS.
  • Prior treatment with ruxolitinib and/or fedratinib monotherapy
  • Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF.
  • Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening.
  • Allogeneic stem cell transplant not planned.
  • Platelet is greater than or equal to 50 × 109/L at screening.
  • Ability to comprehend and willingness to sign a written ICF for the study.
  • Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

  • Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
  • Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening
  • For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
  • Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
  • Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
  • Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
  • Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
  • ECOG performance status ≥ 3
  • Life expectancy less than 24 weeks
  • Not willing to receive RBC or platelet transfusions
  • Participants with laboratory values at screening outside of protocol defined ranges
  • Significant concurrent, uncontrolled medical condition
  • Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor
  • History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful
  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
  • Evidence of HBV or HCV infection or risk of reactivation
  • Known HIV infection.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629508


Contacts
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Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 eumedinfo@incyte.com

Locations
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United States, Louisiana
Tulane University Recruiting
New Orleans, Louisiana, United States, 70112
United States, Maryland
Rcca Md, Llc Recruiting
Bethesda, Maryland, United States, 20817
United States, Missouri
Midamerica Cancer Care Recruiting
Kansas City, Missouri, United States, 64114
United States, New Jersey
New Jersey Hematology Oncology Associates Llc Recruiting
Brick, New Jersey, United States, 08724
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37235
United States, Texas
Texas Oncology - Baylor Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246-2092
Renovatio Clinical Consultants, LLC Recruiting
Spring, Texas, United States, 77380
Austria
Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord Recruiting
Linz, Austria, 70376
Belgium
AZ DELTA Recruiting
Roeselare, Belgium, 08800
Chu Mont Godinne Recruiting
Yvoir, Belgium, 05530
Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Hospital Universitari I Politecnic La Fe Recruiting
Valencia, Spain, 46000
Sponsors and Collaborators
Incyte Corporation
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT04629508    
Obsolete Identifiers: NCT04821791
Other Study ID Numbers: INCB 39110-213/LIMBER-213
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
URL: https://www.incyte.com/our-company/compliance-and-transparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Myelofibrosis
Post-PV Myelofibrosis
Post-ET Myelofibrosis
LIMBER
LIMBER-213
MF
Myeloproliferative Neoplasms
Additional relevant MeSH terms:
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Primary Myelofibrosis
Polycythemia Vera
Polycythemia
Thrombocytosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Bone Marrow Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Neoplasms
Blood Platelet Disorders