Acute myeloid leukemia AML (any French-American-British [FAB] type with the exception of M3 subtype, acute promyelocytic leukemia MedDRA version: 9.1 Level: HLT Classification code 10024291 Term: Leukaemias acute myeloid
Conditions
Interventions
Product Code: ITF2357
Pharmaceutical Form: Capsule, hard
Current Sponsor code: ITF2357
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Product Code: ITF2357
Ph
Sponsors
ITALFARMACO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosis of primary or secondary AML (any French-American-British [FAB] type with the exception of M3 subtype, acute promyelocytic leukemia), in patients who are, for whatever reason, not considered candidates for conventional intensive chemotherapy and for any alternative treatment and: - have relapsed after conventional chemotherapy, or, - have AML that is refractory to at least 1 cycle of chemotherapy, or -untreated elderly patient (>60) not suitable for any alternative treatment. Not a candidate for allogeneic bone marrow transplantation. ECOG Performance score of 0-3 Adequate hepatic and renal function, as defined by serum transaminases =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Treatment with any investigational agent within 3 weeks prior to study therapy. Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure. Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to: Presence of central nervous system (CNS) leukemia. Active uncontrolled bacterial infection. Known human immunodeficiency virus (HIV) infection. Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months. Pregnancy or breast-feeding. Malabsorption syndromes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Number of subjects experiencing DLT at given dose level;Main Objective: To determine the maximum tolerated dose (MTD) of ITF2357 administered for 4 consecutive weeks;Secondary Objective: To assess the safety of ITF2357 To assess the anti-leukemic activity of ITF2357 To assess overall survival. To evaluate PK profile of ITF 2357 in AML patients | — |
Countries
Italy
Outcome results
None listed