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

Sponsor

Incyte Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT01633372

Collaborator

(none)

Enrollment

Locations

Arms

107.4

Actual Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
MPN (Myeloproliferative Neoplasms)	Drug: itacitinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

87 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Jul 16, 2012

Actual Primary Completion Date :

Dec 31, 2013

Actual Study Completion Date :

Jun 29, 2021

Arms and Interventions

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

Outcome Measures

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 [Baseline and Week 12]

Secondary Outcome Measures

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).]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Birmingham Hematology Oncology Associates, LLC	Birmingham	Alabama	United States
2	Mayo Clinic, Arizona	Scottsdale	Arizona	United States
3	UCLA Hematology & Oncology	Los Angeles	California	United States
4	Emory University	Atlanta	Georgia	United States
5	St Agnes Hospital	Baltimore	Maryland	United States
6	University of Michigan Cancer Center	Ann Arbor	Michigan	United States
7	Mount Sinai School of Medicine	New York	New York	United States
8	Oregon Health & Science University	Portland	Oregon	United States
9	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States
10	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania	United States
11	South Carolina Oncology & Associates	Columbia	South Carolina	United States
12	Boston Baskin Cancer Foundation, Inc.	Memphis	Tennessee	United States
13	Tennessee Oncology	Nashville	Tennessee	United States
14	MD Anderson Cancer Center	Houston	Texas	United States
15	St Vincent's Hospital	Darlinghurst	New South Wales	Australia
16	St. George Hospital	Kogarah	New South Wales	Australia
17	Box Hill Hospital	Box Hill	Victoria	Australia
18	Frankston Hospital	Frankston	Victoria	Australia
19	Cross Cancer Institute	Edmonton	Alberta	Canada
20	St. Paul's Hospital	Vancouver	British Columbia	Canada
21	Princess Margaret Hospital	Toronto	Ontario	Canada
22	St. Mary's Hospital	Montreal	Quebec	Canada