Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera
Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study was to evaluate the efficacy of Givinostat in combination
with hydroxyurea in patients with JAK2V617F-positive Polycythemia Vera (PV) non-responders to
the maximum tolerated dose of hydroxyurea monotherapy.
The secondary objectives of this study were:
- To evaluate the safety and tolerability of Givinostat in combination with hydroxyurea in
patients with JAK2V617Fpositive PV non-responders to the maximum tolerated dose of
hydroxyurea monotherapy;
- To explore the impact in terms of efficacy and tolerability of Givinostat 50 mg dose
escalation in patients not achieving at least a partial response at the time when the
primary endpoint was assessed (week 12);
- To evaluate the molecular response (JAK2 mutated allele burden) by quantitative Real
Time-Polymerase Chain Reaction (RT-PCR);
- To evaluate the reduction of the fraction of JAK2V617F positive clonogenic progenitors.