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Sponsored by: |
Exelixis |
Information provided by: | Exelixis |
ClinicalTrials.gov Identifier: | NCT00522574 |
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 |
Genetics Home Reference related topics: | hemophilia |
ChemIDplus related topics: | Gelatin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Roberta Steere, MS, MBA, CCRA | 315-858-2040 | roberta.steere@bluebell.ppdi.com |
United States, California | |||||
UCSF - Division of Hematology/Oncology | Recruiting | ||||
San Francisco, California, United States, 94143 | |||||
Contact: Patrycija Olszynski 415-502-1564 polszynski@medicine.ucsf.edu | |||||
Principal Investigator: Neil Shah, MD | |||||
United States, Florida | |||||
H. Lee Moffitt Cancer Center & Research Institute | Recruiting | ||||
Tampa, Florida, United States, 33612 | |||||
Contact: Debra VanDonkelaar 813-745-4626 Debra.VanDonkelaar@moffitt.org | |||||
Principal Investigator: Lubomir Sokol, MD | |||||
United States, Massachusetts | |||||
Dana Farber Cancer Institute | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Contact: Sara Guterman sguterman@partners.org | |||||
Principal Investigator: Martha Wadleigh, MD | |||||
United States, New York | |||||
Mt. Sinai School of Medicine | Not yet recruiting | ||||
New York, New York, United States, 10029 | |||||
Contact: Amy Rodriguez, RN 212-241-4546 amy.rodriguez@mssm.edu | |||||
Principal Investigator: Ronald Hoffman, MD | |||||
United States, Texas | |||||
MD Anderson Cancer Center | Recruiting | ||||
Houston, Texas, United States, 77030 | |||||
Contact: Mary Ann Richie, RN 713-794-5478 mareese@mdanderson.org | |||||
Principal Investigator: Srdan Verstovsek, MD, PhD |
Exelixis |
Responsible Party: | Exelixis ( Lynne Bui, MD/Senior Director, Clinical Research ) |
Study ID Numbers: | XL019-001 |
First Received: | August 27, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00522574 |
Health Authority: | United States: Food and Drug Administration |
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