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

Phase 2

Completed

• Conditions: MPN (Myeloproliferative Neoplasms)
• Interventions: Drug: itacitinib

• Registration Number: NCT01633372
• Lead Sponsor: Incyte Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-29
• Study First Posted: 2012-07-04
• Study Start: 2012-07-16
• Primary Completion: 2013-12-31
• Disposition First Submitted: 2014-03-26
• Disposition First Submitted QC: 2014-03-26
• Disposition First Posted: 2014-04-22
• Study Completion: 2021-06-29
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
itacitinib 100 mg	itacitinib	itacitinib 100 mg twice a day
itacitinib 200 mg	itacitinib	itacitinib 200 mg twice a day
itacitinib 600 mg	itacitinib	itacitinib 600 mg once a day
itacitinib 400 mg	itacitinib	itacitinib 400 mg once a day
itacitinib 300 mg	itacitinib	itacitinib 300 mg once a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (22)

Emory University; 🇺🇸 Atlanta, Georgia, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St Agnes Hospital; 🇺🇸 Baltimore, Maryland, United States

St Vincent's Hospital; 🇦🇺 Darlinghurst, New South Wales, Australia

Mayo Clinic, Arizona; 🇺🇸 Scottsdale, Arizona, United States

St. George Hospital; 🇦🇺 Kogarah, New South Wales, Australia

Western Pennsylvania Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

Boston Baskin Cancer Foundation, Inc.; 🇺🇸 Memphis, Tennessee, United States

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Birmingham Hematology Oncology Associates, LLC; 🇺🇸 Birmingham, Alabama, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Tennessee Oncology; 🇺🇸 Nashville, Tennessee, United States

South Carolina Oncology & Associates; 🇺🇸 Columbia, South Carolina, United States

UCLA Hematology & Oncology; 🇺🇸 Los Angeles, California, United States

University of Michigan Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Box Hill Hospital; 🇦🇺 Box Hill, Victoria, Australia

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia

St. Mary's Hospital; 🇨🇦 Montreal, Quebec, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States