chronic myeloproliferative diseases MedDRA version: 6.1 Level: HLT Classification code 10028578
Conditions
Interventions
Product Name: dietyl-[6-(4-hydroxycarbamoyl-phenylcarbamoyloxymethil)-naphtalen-2-ylmethyl]-NH4Cl monohydrate
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg/kg
Sponsors
ITALFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed Informed Consent Form Male or female, age ≥ 18 years Confirmed diagnosis of PV/ET/MF according to the revised WHO criteria JAK-2 V617F positivity In need of cytoreductive therapy when hydroxyurea is not indicated (e.g. young patients) or when refractoriness to the drug is documented Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Active bacterial or fungal infection requiring antimicrobial treatment on Day 1 Patients of childbearing potential without a negative pregnancy test prior to initiation of the study drug Pregnancy or lactation A marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval > 450 ms, according to Bazett?s correction formula ? see appendix G for the formula) The use of concomitant medications that prolong the QT/QTc interval (see appendix F for full list) Concomitant acute coronary syndromes; uncontrolled hypertension 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 TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) Active EBV infection (i.e. positive serology IgM) Known HIV infection Active hepatitis B and/or C infection History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding 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 ECOG performance status 3 or greater Platelets count 10% within 14 days before enrolment Serum creatinine >2xULN Total serum bilirubin >1.5xULN Serum AST/ALT > 3xULN Interferon alpha within 14 days before enrolment Hydroxyurea within 14 days before enrolment Anagrelide within 7 days before enrolment Any other investigational drug within 28 days before enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and safety of ITF 2357 in the treatment of patients with JAK2 V617F positive myeloproliferative diseases (PV, ET, MF). Efficacy will be evaluated by ad hoc haematological and clinical criteria for PV and ET, and by internationally established response criteria for MF. Safety will be evaluated by number of subjects experiencing an AE, type, frequency, severity, timing and relatedness of AEs (including changes in vital signs and clinical laboratory results;Secondary Objective: to evaluate the JAK2 mutated allele burden by quantitative RT PCR;Primary end point(s): The number of Objective Responses (OR) The number of subjects experiencing an adverse event | — |
Countries
Italy
Outcome results
None listed