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

MPN (Myeloproliferative Neoplasms) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633372
• Other study ID #: INCB 39110-230
• Status: Completed
• Phase: Phase 2
• Start date: July 16, 2012
• Est. completion date: June 29, 2021

Study information

• Verified date: August 2021
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 29, 2021
• Est. primary completion date: December 31, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• MPN (Myeloproliferative Neoplasms)
• Myeloproliferative Disorders
• Polycythemia Vera
• Primary Myelofibrosis

Intervention

Drug:
• itacitinib

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of subjects with >/= 35% reduction in spleen volume, and mean percent change in spleen volume		Baseline, Week 12 and Week 24
Secondary	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.
Secondary	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).