Clinical Trials /

SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

NCT03008187

Description:

The purpose of the clinical trial is to identify the highest dose of SEL24/MEN1703 drug with acceptable safety profile and that can be used in patients with Acute Myeloid Leukemia.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: SEL24 in Patients With AML
  • Official Title: A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: CLI24-001
  • NCT ID: NCT03008187

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
SEL24SEL24-B489SEL24

Purpose

Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.

Detailed Description

      This is a Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD
      (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected
      for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24
      will be further assessed in patients who are unfit to receive intensive chemotherapy.

      Part 1 will commence with an accelerated dose escalation design for the first 4 cohorts. The
      study will then follow a 3+3 design from Cohort 5 onwards in order to provide adequate PK
      profile data. In Part 1 the MTD is defined as the highest dose at which no more than 1 in up
      to 6 patients experience a DLT during Cycle 1. The dose escalation rules to be followed
      during Part 1 of the study are described in the study protocol.

      The highest SEL24 dose level considered to be well tolerated in 6 patients, and to have
      optimal PK and PD characteristics, will be called the RD and will be selected for further
      evaluation in Part 2.

      Part 2 will enroll patients at the RD identified in Part 1. The treatment groups in Part 2
      will be opened for recruitment based on recommendation by the Investigators, Medical Monitor
      and Sponsor.
    

Trial Arms

NameTypeDescriptionInterventions
SEL24ExperimentalSEL24 will be taken orally once daily for 14 consecutive days over a 21-day treatment cycle. The cohort dose may be escalated by an increase in the daily dose level during the study based on the dose escalation rules. Continuation of the study treatment may be discussed between the investigator and the Sponsor on a case by case basis. The DMC may also advise on the suitability of an individual patient to continue to receive study treatment. Patients who experience a DLT will be permitted to receive further treatment with SEL24 according to the dose modification rules described in the study protocol.
  • SEL24

Eligibility Criteria

        Inclusion Criteria:

          -  diagnosis of AML

          -  no standard therapeutic options available (to be supplemented)

        Exclusion Criteria:

          -  anti-cancer treatments (including cytotoxic chemotherapy, radiotherapy, hormonal
             therapy, biologic, immunotherapy or investigational drugs) received within 14 days or
             5 half-lives for targeted therapies (whichever is shorter) before first dose of study
             drug (to be supplemented)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicity (DLT) evaluation
Time Frame:DLTs in patients during their first 21-day treatment cycle
Safety Issue:
Description:Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Selvita S.A.

Trial Keywords

  • AML

Last Updated

March 29, 2017