search
Back to results

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

Primary Purpose

MPN (Myeloproliferative Neoplasms)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
itacitinib
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MPN (Myeloproliferative Neoplasms) focused on measuring Primary Myelofibrosis, PMF, Post Polycythemia Vera Fibrosis, PPV-MF, Post Essential Thrombocythemia Myelofibrosis, PET-MF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Hematology Oncology Associates, LLC
  • Mayo Clinic, Arizona
  • UCLA Hematology & Oncology
  • Emory University
  • St Agnes Hospital
  • University of Michigan Cancer Center
  • Mount Sinai School of Medicine
  • Oregon Health & Science University
  • University of Pennsylvania Health System
  • Western Pennsylvania Hospital
  • South Carolina Oncology & Associates
  • Boston Baskin Cancer Foundation, Inc.
  • Tennessee Oncology
  • MD Anderson Cancer Center
  • St Vincent's Hospital
  • St. George Hospital
  • Box Hill Hospital
  • Frankston Hospital
  • Cross Cancer Institute
  • St. Paul's Hospital
  • Princess Margaret Hospital
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

itacitinib 100 mg

itacitinib 200 mg

itacitinib 300 mg

itacitinib 400 mg

itacitinib 600 mg

Arm Description

itacitinib 100 mg twice a day

itacitinib 200 mg twice a day

itacitinib 300 mg once a day

itacitinib 400 mg once a day

itacitinib 600 mg once a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
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
Safety and tolerability of itacitinib as measured by adverse events.

Full Information

First Posted
June 26, 2012
Last Updated
August 25, 2021
Sponsor
Incyte Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01633372
Brief Title
An Open Label Study of Itacitinib Administered Orally in Patients With Myelofibrosis
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 16, 2012 (Actual)
Primary Completion Date
December 31, 2013 (Actual)
Study Completion Date
June 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MPN (Myeloproliferative Neoplasms)
Keywords
Primary Myelofibrosis, PMF, Post Polycythemia Vera Fibrosis, PPV-MF, Post Essential Thrombocythemia Myelofibrosis, PET-MF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)

8. Arms, Groups, and Interventions

Arm Title
itacitinib 100 mg
Arm Type
Experimental
Arm Description
itacitinib 100 mg twice a day
Arm Title
itacitinib 200 mg
Arm Type
Experimental
Arm Description
itacitinib 200 mg twice a day
Arm Title
itacitinib 300 mg
Arm Type
Experimental
Arm Description
itacitinib 300 mg once a day
Arm Title
itacitinib 400 mg
Arm Type
Experimental
Arm Description
itacitinib 400 mg once a day
Arm Title
itacitinib 600 mg
Arm Type
Experimental
Arm Description
itacitinib 600 mg once a day
Intervention Type
Drug
Intervention Name(s)
itacitinib
Other Intervention Name(s)
INCB039110
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume
Time Frame
Baseline, Week 12 and Week 24
Title
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.
Title
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Assad, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Hematology Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Mayo Clinic, Arizona
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
UCLA Hematology & Oncology
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
St Agnes Hospital
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
South Carolina Oncology & Associates
City
Columbia
State/Province
South Carolina
Country
United States
Facility Name
Boston Baskin Cancer Foundation, Inc.
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
St Vincent's Hospital
City
Darlinghurst
State/Province
New South Wales
Country
Australia
Facility Name
St. George Hospital
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Frankston Hospital
City
Frankston
State/Province
Victoria
Country
Australia
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
St. Mary's Hospital
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
27789678
Citation
Mascarenhas JO, Talpaz M, Gupta V, Foltz LM, Savona MR, Paquette R, Turner AR, Coughlin P, Winton E, Burn TC, O'Neill P, Clark J, Hunter D, Assad A, Hoffman R, Verstovsek S. Primary analysis of a phase II open-label trial of INCB039110, a selective JAK1 inhibitor, in patients with myelofibrosis. Haematologica. 2017 Feb;102(2):327-335. doi: 10.3324/haematol.2016.151126. Epub 2016 Oct 27.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs