E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute myeloid leukemia AML (any French-American-British [FAB] type with the exception of M3 subtype, acute promyelocytic leukemia |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10024291 |
E.1.2 | Term | Leukaemias acute myeloid |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the maximum tolerated dose (MTD) of ITF2357 administered for 4 consecutive weeks |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOCINETICA/FARMACODINAMICA: Versione: Data: Titolo: Obiettivi:
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E.3 | Principal 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. |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of subjects experiencing DLT at given dose level |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |