CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea +1 moredrug
Likely dose
GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyureafrom record
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Search/NCT00928707
NCT00928707Phase 2Completed
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Phase II Study of the Histone-deacetylase Inhibitor GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Patients With JAK2V617F Positive Polycythemia Vera Non-responder to Hydroxyurea Monotherapy.

Italfarmaco·interventional·Posted Jun 26, 2009·Updated Oct 31, 2019

In Brief

A Phase 2 clinical trial evaluating GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyurea and GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyurea for Polycythemia Vera. Completed, enrolled 45 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycythemia Vera
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 26, 2009
Enrollment StartJun 1, 2009
Primary CompletionJul 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.0 years ago

Interventions

GIVINOSTAT (ITF2357) 50 mg o.d. + MTD Hydroxyureadrug

50 mg o.d. of GIVINOSTAT + MTD of HU monotherapy

GIVINOSTAT (ITF2357) 50 mg b.i.d. + MTD Hydroxyureadrug

50 mg b.i.d. of GIVINOSTAT + MTD HU monotherapy