Clinical Trial: Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera

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

Official Title: Phase II Study of the Histone-deacetylase Inhibitor GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Patients With JAK2V617F Positive Polycythemia Vera Non-responde

Brief Summary:

This is a multicentre, randomized, open-label, phase II study testing GIVINOSTAT (ITF2357) in combination with hydroxyurea in a population of patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.

Recruited patients will be randomly assigned to one of the following treatment groups:

  • group A: 50 mg o.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study;
  • group B: 50 mg b.i.d. of oral GIVINOSTAT (ITF2357) in combination with the maximum tolerated dose of hydroxyurea monotherapy already in use before admission to the study.

The two groups will be balanced for number and for Centre in order to provide valuable information on both treatment regimens.

In both groups assigned doses shall remain stable until week 12, which is when the primary endpoint is assessed, unless specific tolerability issues arise which impose dose reduction.

After the primary endpoint assessment at week 12, one of the following treatment schedules will be chosen case by case on the basis of the achieved clinical response and continued for up to 12 further weeks:

  • Partial or Complete Response at week 12:
  • group A: continue 50 mg o.d.;
  • group B: continue 50 mg b.i.d.;
  • No Response at week 12:
  • group A: increase to 50 mg b.i.d.;

  • Detailed Summary:
    Sponsor: Italfarmaco

    Current Primary Outcome: To evaluate the efficacy of GIVINOSTAT (ITF2357) in combination with hydroxyurea in patients with JAK2V617F positive Polycythemia Vera non-responders to the maximum tolerated dose of hydroxyurea monotherapy. [ Time Frame: after 12 weeks of treatment ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome: To evaluate the safety and tolerability of GIVINOSTAT-HU combination in patients with JAK2V617F positive PV NR to the MTD of HU monotherapy; to evaluate the molecular response. [ Time Frame: after 24 weeks of treatment ]

    Original Secondary Outcome: Same as current

    Information By: Italfarmaco

    Dates:
    Date Received: June 25, 2009
    Date Started: June 2009
    Date Completion:
    Last Updated: September 17, 2012
    Last Verified: September 2012