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

Sponsor
Italfarmaco
Study ID
NCT00928707
Phase
PHASE2
Status
Completed

Conditions

  • Polycythemia Vera

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 30, 2009
Status verified
Oct 2019
Primary completion
Jul 31, 2011
Completion
Oct 31, 2011

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GIVINOSTAT + MTD Hydroxyurea (HU)_1
    50 mg o.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy
  • Experimental: GIVINOSTAT + MTD Hydroxyurea (HU)_2
    50 mg b.i.d. of GIVINOSTAT + maximum tolerated dose (MTD) of Hydroxyurea (HU) monotherapy

Primary Outcome Measure

Percentage of Patients With Overall Haematological Response at Week 12. [ Time Frame: At week 12 of treatment ]

Related Studies