Status:
COMPLETED
Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera
Lead Sponsor:
Italfarmaco
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 t...
Detailed Description
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-res...
Eligibility Criteria
Inclusion
- Written Informed Consent.
- Age ≥18 years.
- Confirmed diagnosis of Polycythemia Vera according to the revised World Health Organization (WHO) criteria.
- JAK2V617F positivity.
- Non-response to the maximum tolerated dose of hydroxyurea monotherapy for at least 3 months.
- ECOG (Eastern Cooperative Oncology Group) performance status \<3.
- Use of an effective means of contraception for women of childbearing potential and men with partners of childbearing potential.
- Willingness and capability to comply with the requirements of the study.
Exclusion
- Active bacterial or mycotic infection requiring antimicrobial treatment.
- Pregnancy or lactation.
- A marked baseline prolongation of QT/QTc (corrected) interval (e.g. repeated demonstration of a QTc interval \> 450 ms, according to Bazett's correction formula).
- Use of concomitant medications that prolong the QT/QTc interval.
- Clinically significant cardiovascular disease including:
- Uncontrolled hypertension, myocardial infarction, unstable angin, within 6 months from study start;
- New York Heart Association (NYHA) Grade II or greater congestive heart failure;
- History of any cardiac arrhythmia requiring medication (irrespective of its severity);
- A history of additional risk factors for torsade de pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
- Positive blood test for HIV (Human Immunodeficiency Virus)
- Active HBV (Hepatitis B Virus) and/or HCV (Hepatitis C Virus) infection.
- Platelets count \<100x109/L within 14 days before enrolment.
- Absolute neutrophil count \<1.2x109/L within 14 days before enrolment.
- Serum creatinine \>2xULN (upper limit of normal).
- Total serum bilirubin \>1.5xULN.
- Serum aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 3xULN.
- History of other diseases, metabolic dysfunctions, physical examination findings, or clinical laboratory findings giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk from treatment complications.
- Interferon alpha within 14 days before enrolment.
- Anagrelide within 7 days before enrolment.
- Any other investigational drug within 28 days before enrolment.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00928707
Start Date
June 1 2009
End Date
October 1 2011
Last Update
October 31 2019
Active Locations (22)
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1
Azienda Ospedaliero-Universitaria Policlinico Consorziale di Bari
Bari, BA, Italy, 70124
2
Azienda Ospedaliera Santa Croce e Carle di Cuneo
Cuneo, CN, Italy, 12100
3
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi di Catania
Catania, CT, Italy, 95126
4
Fondazione I. R. C. C. S. - Casa sollievo della sofferenza di San Giovanni Rotondo
San Giovanni Rotondo, FG, Italy, 71013