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

August 25, 2021 updated by: Incyte Corporation

An Open-Label, Multiple Simon 2-Stage Study of Itacitinib Administered Orally to Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera Myelofibrosis (PPV-MF) or Post Essential Thrombocythemia Myelofibrosis (PET-MF)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • St Vincent's Hospital
      • Kogarah, New South Wales, Australia
        • St. George Hospital
    • Victoria
      • Box Hill, Victoria, Australia
        • Box Hill Hospital
      • Frankston, Victoria, Australia
        • Frankston Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St. Paul's Hospital
    • Ontario
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • St. Mary's Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Birmingham Hematology Oncology Associates, LLC
    • Arizona
      • Scottsdale, Arizona, United States
        • Mayo Clinic, Arizona
    • California
      • Los Angeles, California, United States
        • UCLA Hematology & Oncology
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
    • Maryland
      • Baltimore, Maryland, United States
        • St Agnes Hospital
    • Michigan
      • Ann Arbor, Michigan, United States
        • University of Michigan Cancer Center
    • New York
      • New York, New York, United States
        • Mount Sinai School of Medicine
    • Oregon
      • Portland, Oregon, United States
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • University of Pennsylvania Health System
      • Pittsburgh, Pennsylvania, United States
        • Western Pennsylvania Hospital
    • South Carolina
      • Columbia, South Carolina, United States
        • South Carolina Oncology & Associates
    • Tennessee
      • Memphis, Tennessee, United States
        • Boston Baskin Cancer Foundation, Inc.
      • Nashville, Tennessee, United States
        • Tennessee Oncology
    • Texas
      • Houston, Texas, United States
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy.
  • Must score at least 1 point on the Dynamic International Prognostic Scoring System (DIPSS) for prognostic risk factors and have peripheral blast count <10% at both Screening and Baseline hematology assessments.
  • Subjects must discontinue all drugs used to treat underlying MF disease no later than Day -14.
  • Subjects must have hemoglobin value >/= 8.0g/dL and be willing to receive blood transfusions, have a platelet count >/=50x10^9/L and absolute neutrophil count (ANC) >/= 1x10^9/L.
  • Subjects must have palpable spleen or history of splenectomy
  • Active symptoms at the screening visit

Exclusion Criteria:

  • Women who are pregnant or breastfeeding, and men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
  • Subjects with impaired liver function, end stage renal disease on dialysis or clinically significant concurrent infections requiring therapy.
  • Subjects with unstable cardiac function or invasive malignancies 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: itacitinib 100 mg
itacitinib 100 mg twice a day
Drug: itacitinib
Other Names:
  • INCB039110
EXPERIMENTAL: itacitinib 200 mg
itacitinib 200 mg twice a day
Drug: itacitinib
Other Names:
  • INCB039110
EXPERIMENTAL: itacitinib 300 mg
itacitinib 300 mg once a day
Drug: itacitinib
Other Names:
  • INCB039110
EXPERIMENTAL: itacitinib 400 mg
itacitinib 400 mg once a day
Drug: itacitinib
Other Names:
  • INCB039110
EXPERIMENTAL: itacitinib 600 mg
itacitinib 600 mg once a day
Drug: itacitinib
Other Names:
  • INCB039110

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
Time Frame: Baseline, Week 12 and Week 24
Baseline, Week 12 and Week 24
Proportion of transfusion dependent subjects who exhibit changes in transfusion frequency over any 12 week period on study and proportion of transfusion independent subjects who exhibit changes in hemoglobin level
Time Frame: Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.
Baseline to Week 12; Week 13 to Week 24 through the end of study or study termination visit.
Safety and tolerability of itacitinib as measured by adverse events.
Time Frame: Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).
Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 16, 2012

Primary Completion (ACTUAL)

December 31, 2013

Study Completion (ACTUAL)

June 29, 2021

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 29, 2012

First Posted (ESTIMATE)

July 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCB 39110-230

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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