Last updated on February 2019

Study of MEN1112 Intravenous Infusion in Relapsed or Refractory Acute Myeloid Leukemia

Brief description of study

The purpose of this study is to assess the safety of MEN1112, given as intravenous infusion, in patients with relapsed or refractory AML. Pharmacokinetics, clinical activity and potential immunogenicity of MEN1112 will be evaluated as well.

Detailed Study Description

This trial is designed as an open label, non randomised, dose escalation and cohort expansion, first administration to human study to be conducted in approximately 20 European sites. The study is aiming to identify the Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD), to assess the pharmacokinetics and to determine the clinical activity and potential immunogenicity of MEN1112, administered as IV infusion given once every week in a 21 days cycle in patients with relapsed/refractory acute myeloid leukemia (AML).

Approximately 50 male and female 18 years-old patients, with a documented diagnosis of relapsed or refractory AML (not M3 FAB subtype), will be treated in the study, which consists of two steps.

Step 1 is the dose escalation phase according to a 3+3 patients cohort design.Incremental mg/Kg doses will be tested given at day 1, 8 and 15 of a 21-day cycle. Briefly, MEN1112 doses are to be administered to 3 patients; if no DLT is observed in a cohort of 3 DLT evaluable patients at a given dose level, the next cohort of 3 new patients will be treated with the next higher dose. In case of DLT occurrence by one of the three patients at any dose, the cohort will be expanded to 6 DLT evaluable patients at the same dose level. If two or more patients at a given dose level exhibit DLT, the dose escalation phase will be concluded as the MTD will be identified as one dose level below the one at which 2 DLT out of 6 treated patients occur.

Step 2 is the cohort expansion phase which will include patients treated at the MTD or the maximum dose level judged to be tolerable.

In each study Step, patients will be given two induction cycles of MEN1112 followed by a three weeks End of Induction period. Patients will then undergo to 4 post-induction/maintenance visits every 28 days (maintenance administration is allowed in patients who achieve a clinical benefit based on Investigator's judgement) and to an End of Study Visit. Along the study period, adverse events, changes in hematology/serum biochemistry parameters and bone marrow treatment response will represent the major clinical findings to be monitored on regular basis. The individual experimental clinical phase will last up to 6 months (except for female patients of childbearing potential that will undergo monthly pregnancy test until 6 months from the last study drug administration) encompassing 40 planned visits at site, including Screening, Induction, End of Induction, Post-induction/Maintenance and the End of Study visit.

Clinical Study Identifier: NCT02353143

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