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

NCT00928707 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-10-31

Study results available
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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.

Conditions

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Principal Investigators

  • Alessandro Rambaldi, MD · Azienda Ospedaliera Ospedali Riuniti di Bergamo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-07-31
Completion
2011-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928707 on ClinicalTrials.gov