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| Sponsor: | Exelixis |
|---|---|
| Information provided by: | Exelixis |
| ClinicalTrials.gov Identifier: | NCT00522574 |
Purpose
The purpose of this study is to evaluate the safety and tolerability of XL019 in adults with myelofibrosis. XL019 is a selective inhibitor of the cytoplasmic tyrosine kinase JAK2. JAK2 is activated by cytokine and growth factor receptors and phosphorylates members of the STAT family of inducible transcription factors. Activation of the JAK/STAT pathway promotes cell growth and survival, and is a common feature of human tumors. JAK2 is activated by mutation in the majority of patients with myelofibrosis, polycythemia vera and essential thrombocytosis and appears to drive the inappropriate growth of blood cells in these conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Myeloproliferative Disorders Myelofibrosis Polycythemia Vera Thrombocythemia, Essential |
Drug: XL019 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Myelofibrosis |
| Estimated Enrollment: | 100 |
| Study Start Date: | August 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| UCSF - Division of Hematology/Oncology | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, New York | |
| Mt. Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
More Information
| Responsible Party: | Chunyan Song, MD/Senior Manager, Clinical Research, Exelixis |
| ClinicalTrials.gov Identifier: | NCT00522574 History of Changes |
| Other Study ID Numbers: | XL019-001 |
| Study First Received: | August 27, 2007 |
| Last Updated: | April 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Myeloproliferative Disorders |
|
Primary Myelofibrosis Myeloproliferative Disorders Polycythemia Polycythemia Vera Thrombocythemia, Essential Thrombocytosis |
Bone Marrow Diseases Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemorrhagic Disorders |