SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT00606307

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase IIA Study of the Histone-deacetylase Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases

In recent years several reports have documented that Histone Deacetylases (HDACs) inhibitors induce neoplastic cells to undergo growth arrest, differentiation and/or apoptotic cell death. Recently, inhibitors of HDACs has also been shown to inhibit endothelial cell proliferation and angiogenesis in vivo. Several HDAC-inhibitors are currently in clinical trials as novel anticancer agents. Among these agents, ITF2357 has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells from patients with myeloproliferative disorders carrying the JAK2 V617F mutation. The aim of the present study is to evaluate the efficacy and safety of ITF2357 in the treatment of polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)

NCT00606307 Myeloproliferative Diseases
MeSH: Myeloproliferative Disorders
HPO: Myeloproliferative disorder

1 Interventions

Name: ITF2357

Description: 50 mg b.i.d. PO every day

Type: Drug

ITF2357


Primary Outcomes

Measure: Efficacy evaluated by ad hoc haematological and clinical criteria for PV and ET, and by internationally established response criteria for MF. Safety evaluated by number of subjects experiencing an AE

Time: 3 months

Secondary Outcomes

Measure: evaluate the JAK2 mutated allele burden by quantitative RT PCR

Time: 3 months

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 V617F

A Phase IIA Study of the Histone-deacetylase Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases. --- V617F ---

Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases In recent years several reports have documented that Histone Deacetylases (HDACs) inhibitors induce neoplastic cells to undergo growth arrest, differentiation and/or apoptotic cell death. --- V617F ---

Among these agents, ITF2357 has most recently been shown to be a potent inhibitor of the autonomous proliferation of haematopoietic cells from patients with myeloproliferative disorders carrying the JAK2 V617F mutation. --- V617F ---

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. --- V617F ---

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 <100x109/L within 14 days before enrolment - Absolute neutrophil count <1.2x109/L within 14 days before enrolment - Percentage of blast cells in peripheral blood >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 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. --- V617F ---



HPO Nodes


HPO:
Myeloproliferative disorder
Genes 12
GATA2 MPL SH2B3 PDGFRA BCR JAK2 PDGFRB ABL1 THPO CALR RUNX1 GATA1