NCT00522574

A Safety Study of XL019 in Adults With Myelofibrosis

A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Myelofibrosis

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Exelixis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myeloproliferative Disorders
• Myelofibrosis
• Polycythemia Vera
• Thrombocythemia, Essential

Interventions

Type	Name	Description
DRUG	XL019	gelatin capsules supplied in 5-mg, 25-mg, and 100-mg strengths

Timeline

• Start date: 2007-08-01
• First posted: 2007-08-29
• Last updated: 2011-04-05

Locations

5 sites across 1 country: United States