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The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XL019 | Drug | XL019 capsules administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) | Assessed at each visit | |
| Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019 | Assessed at periodic visits |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV | Assessed during periodic visits | |
| Evaluate preliminary efficacy of XL019 | Assessed weekly or bi-weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine, Center for Health Sciences | Los Angeles | California | 90095 | United States | ||
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| ID | Term |
|---|---|
| D011087 | Polycythemia Vera |
| ID | Term |
|---|---|
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| UCSF - Division of Hematology/Oncology |
| San Francisco |
| California |
| 94143 |
| United States |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa | Florida | 33612 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| Weill Cornell Medical College | New York | New York | 10065 | United States |
| D001855 |
| Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009196 | Myeloproliferative Disorders |