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

NCT01633372 | Completed Phase 2

• 1 other identifier: INCB 39110-230
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 22

Brief Summary

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

Conditions

MPN (Myeloproliferative Neoplasms)

Keywords

Primary Myelofibrosis; PMF; Post Polycythemia Vera Fibrosis; PPV-MF; Post Essential Thrombocythemia Myelofibrosis; PET-MF

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and Week 12

Secondary Outcomes (3)

• Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume

  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

  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.

  Every 4-6 weeks through the end of study or early termination visit (approximately 33 weeks exclusive of the extension phase).

Study Arms (5)

itacitinib 100 mg

EXPERIMENTAL

itacitinib 100 mg twice a day

Drug: itacitinib

itacitinib 200 mg

EXPERIMENTAL

itacitinib 200 mg twice a day

Drug: itacitinib

itacitinib 300 mg

EXPERIMENTAL

itacitinib 300 mg once a day

Drug: itacitinib

itacitinib 400 mg

EXPERIMENTAL

itacitinib 400 mg once a day

Drug: itacitinib

itacitinib 600 mg

EXPERIMENTAL

itacitinib 600 mg once a day

Drug: itacitinib

Interventions

itacitinib DRUG

Also known as: INCB039110

itacitinib 100 mg; itacitinib 200 mg; itacitinib 300 mg; itacitinib 400 mg; itacitinib 600 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (22)

Birmingham Hematology Oncology Associates, LLC

Birmingham, Alabama, United States

Location

Mayo Clinic, Arizona

Scottsdale, Arizona, United States

Location

UCLA Hematology & Oncology

Los Angeles, California, United States

Location

Emory University

Atlanta, Georgia, United States

Location

St Agnes Hospital

Baltimore, Maryland, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

Oregon Health & Science University

Portland, Oregon, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Location

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, United States

Location

South Carolina Oncology & Associates

Columbia, South Carolina, United States

Location

Boston Baskin Cancer Foundation, Inc.

Memphis, Tennessee, United States

Location

Tennessee Oncology

Nashville, Tennessee, United States

Location

MD Anderson Cancer Center

Houston, Texas, United States

Location

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Location

St. George Hospital

Kogarah, New South Wales, Australia

Location

Box Hill Hospital

Box Hill, Victoria, Australia

Location

Frankston Hospital

Frankston, Victoria, Australia

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

St. Mary's Hospital

Montreal, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 27789678 DERIVED

MeSH Terms

Conditions

Myeloproliferative Disorders; Primary Myelofibrosis

Interventions

itacitinib; INCB039110

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Albert Assad, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2012
• First Posted: July 4, 2012
• Study Start: July 16, 2012
• Primary Completion: December 31, 2013
• Study Completion: June 29, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Locations

CA (4); US (14); AU (4)