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This is a study of itacitinib (INCB039110) in patients with myelofibrosis. This study will evaluate safety and efficacy parameters of itacitinib (INCB039110).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| itacitinib 100 mg | Experimental | itacitinib 100 mg twice a day |
|
| itacitinib 200 mg | Experimental | itacitinib 200 mg twice a day |
|
| itacitinib 300 mg | Experimental | itacitinib 300 mg once a day |
|
| itacitinib 400 mg | Experimental | itacitinib 400 mg once a day |
|
| itacitinib 600 mg | Experimental | itacitinib 600 mg once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itacitinib | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Assad, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology Oncology Associates, LLC | Birmingham | Alabama | United States | |||
| Mayo Clinic, Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27789678 | Derived | 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. |
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| 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). |
| Scottsdale |
| Arizona |
| United States |
| UCLA Hematology & Oncology | Los Angeles | California | United States |
| Emory University | Atlanta | Georgia | United States |
| St Agnes Hospital | Baltimore | Maryland | United States |
| University of Michigan Cancer Center | Ann Arbor | Michigan | United States |
| Mount Sinai School of Medicine | New York | New York | United States |
| Oregon Health & Science University | Portland | Oregon | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States |
| Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States |
| South Carolina Oncology & Associates | Columbia | South Carolina | United States |
| Boston Baskin Cancer Foundation, Inc. | Memphis | Tennessee | United States |
| Tennessee Oncology | Nashville | Tennessee | United States |
| MD Anderson Cancer Center | Houston | Texas | United States |
| St Vincent's Hospital | Darlinghurst | New South Wales | Australia |
| St. George Hospital | Kogarah | New South Wales | Australia |
| Box Hill Hospital | Box Hill | Victoria | Australia |
| Frankston Hospital | Frankston | Victoria | Australia |
| Cross Cancer Institute | Edmonton | Alberta | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| Princess Margaret Hospital | Toronto | Ontario | Canada |
| St. Mary's Hospital | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000718170 | itacitinib |
| C000603457 | INCB039110 |
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