Clinical Trial: A Phase 1 Study of XL019 in Adults With Polycythemia Vera

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase 1 Dose-Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of XL019 Administered to Subjects With Polycythemia Vera

Brief Summary: The purpose of this study is to evaluate the safety and tolerability of the JAK2 inhibitor XL019 administered orally in adults with Polycythemia Vera.

Detailed Summary:
Sponsor: Exelixis

Current Primary Outcome:

  • Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [ Time Frame: Assessed at each visit ]
  • Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019 [ Time Frame: Assessed at periodic visits ]


Original Primary Outcome:

  • Safety and tolerability of XL019 as a single agent when orally administered in adults with Polycythemia Vera (PV) [ Time Frame: Assessed at each visit ]
  • Determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) for XL019


Current Secondary Outcome:

  • Evaluate pharmacokinetic and pharmacodynamic parameters of XL019 in adults with PV [ Time Frame: Assessed during periodic visits ]
  • Evaluate preliminary efficacy of XL019 [ Time Frame: Assessed weekly or bi-weekly ]


Original Secondary Outcome: Same as current

Information By: Exelixis

Dates:
Date Received: January 7, 2008
Date Started: December 2007
Date Completion:
Last Updated: August 19, 2015
Last Verified: August 2015