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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004105-11 | EudraCT Number |
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This open-label study is to determine the safety and efficacy of momelotinib in participants with either polycythemia vera (PV) or essential thrombocythemia (ET) who have not yet received treatment with a Janus kinase (JAK) inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Momelotinib 100 mg PV | Experimental | Participants with polycythemia vera will receive 100 mg of momelotinib. |
|
| Momelotinib 200 mg PV | Experimental | Participants with polycythemia vera will receive 200 mg of momelotinib. |
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| Momelotinib 100 mg ET | Experimental | Participants with essential thrombocythemia will receive 100 mg of momelotinib. |
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| Momelotinib 200 mg ET | Experimental | Participants with essential thrombocythemia will receive 200 mg of momelotinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momelotinib | Drug | Momelotinib tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | For the PV Cohort, overall response rate (ORR) is defined as the proportion of participants with all of the following at some point during the treatment period:
For the ET Cohort, overall response rate is defined as the proportion of participants with all of the following at some point during the treatment period:
| Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed overall response rate | Confirmed overall response rate is defined as the proportion of participants who meet all the criteria listed for the primary endpoints of PV or ET, sustained for at least 12 weeks. | Up to 24 weeks |
| Proportion of participants with hematocrit < 45% in the absence of phlebotomy that lasts at least 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Lee, MD, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28622623 | Derived | Verstovsek S, Courby S, Griesshammer M, Mesa RA, Brachmann CB, Kawashima J, Maltzman JD, Shao L, Xin Y, Huang D, Bajel A. A phase 2 study of momelotinib, a potent JAK1 and JAK2 inhibitor, in patients with polycythemia vera or essential thrombocythemia. Leuk Res. 2017 Sep;60:11-17. doi: 10.1016/j.leukres.2017.05.002. Epub 2017 May 30. |
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|
| Up to 24 weeks |
| Proportion of participants with WBC < 10 x 10^9/L that lasts at least 4 weeks | Up to 24 weeks |
| Proportion of participants with platelet count ≤ 400 x 10^9/L that lasts at least 4 weeks | Up to 24 weeks |
| Proportion of participants with resolution of palpable splenomegaly that lasts at least 4 weeks | Up to 24 weeks |
| Proportion of participants with ≥ 10 point decrease in modified Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPNSAF TSS) compared to baseline that lasts at least 12 weeks | Up to 24 weeks |
| Whittier |
| California |
| United States |
| Tupelo | Mississippi | United States |
| St Louis | Missouri | United States |
| Houston | Texas | United States |
| Frankston | Victoria | Australia |
| Parkville | Victoria | Australia |
| Vancouver | British Columbia | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| La Tronche | France |
| Nantes | France |
| Paris | France |
| Dresden | Germany |
| Minden | Germany |
| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| D013920 | Thrombocythemia, Essential |
| D011086 | Polycythemia |
| D013922 | Thrombocytosis |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D001778 | Blood Coagulation Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C546012 | N-(cyanomethyl)-4-(2-((4-(4-morpholinyl)phenyl)amino)-4-pyrimidinyl)benzamide |
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