Description:
The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703 and to further investigate its safety profile in patients with Acute Myeloid Leukemia.
The purpose of the clinical trial is to identify the maximum tolerated dose of SEL24/MEN1703 and to further investigate its safety profile in patients with Acute Myeloid Leukemia.
Recruiting
Phase 1/Phase 2
Drug | Synonyms | Arms |
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SEL24 | SEL24-B489 | SEL24 |
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.
Name | Type | Description | Interventions |
---|---|---|---|
SEL24 | Experimental | SEL24 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. |
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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 |
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 |
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Selvita S.A. |
March 29, 2017