Clinical Trial: Pilot Study of Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II, Open-Label, Efficacy and Safety, Ascending Dose, Pilot Study of be Fostamatinib Disodium/R935788 for the Treatment of Adult Refractory Immune Thrombocytopenic Purpura

Brief Summary: The purpose of this study is to determine whether Fostamatinib Disodium is safe and effective in the treatment of Adult Refractory Immune Thrombocytopenic Purpura (ITP).

Detailed Summary: Patients with chronic refractory ITP are eligible for a 6- to 12-week therapeutic trial. After 24 months of treatment, patients who continue to demonstrate a sustained response, in the investigator's judgment, will be offered the opportunity to receive ongoing therapy.
Sponsor: Rigel Pharmaceuticals

Current Primary Outcome:

  • Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 2 [ Time Frame: 2 weeks ]
  • Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 6 [ Time Frame: 6 Weeks ]
  • Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 12 [ Time Frame: 12 Weeks ]
  • Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Week 24 [ Time Frame: 24 Weeks ]
  • Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 12 [ Time Frame: 12 Months ]
  • Summary of Patients Whose Platelet Count Increased by at Least 20,000/mm3 From Baseline to a Total of 30,000/mm3 or More - Month 24 [ Time Frame: 24 Months ]


Original Primary Outcome: The primary objective of this pilot study is to assess the preliminary efficacy of R788 in the treatment of chronic refractory ITP as measured by platelet response. [ Time Frame: Study ]

Current Secondary Outcome:

Original Secondary Outcome: The secondary objective of this pilot-study is to assess the safety of R788 in the treatment of chronic refractory ITP using standard safety tests. [ Time Frame: study ]

Information By: Rigel Pharmaceuticals

Dates:
Date Received: June 25, 2008
Date Started: January 2007
Date Completion:
Last Updated: May 3, 2016
Last Verified: May 2016