Multicentre, open label, uncontrolled, pilot, phase II study of oral ITF2357 in subjects with acute myeloid leukemia refractory/resistant and/or not suitable for any alternative therapy - ND

Conditions: Acute myeloid leukemia AML (any French-American-British [FAB] type with the exception of M3 subtype, acute promyelocytic leukemia
MedDRA version: 9.1Level: HLTClassification code 10024291Term: Leukaemias acute myeloid

Registration Number: EUCTR2005-005321-63-IT

Lead Sponsor: ITALFARMACO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 <2.5x ULN, bilirubin <1.5x ULN and creatinine <1.5x ULN.
Age 18 years or greater.
Documentation of written informed consent to participate in the trial.
Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
At least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
Either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.
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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To assess the anti-leukemic activity of ITF2357 <br>To assess overall survival.<br>To evaluate PK profile of ITF 2357 in AML patients

Secondary Outcome Measures