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.
Clinical Trials /
SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
NCT03008187
Related Conditions:
- Acute Myeloid Leukemia
Recruiting Status:
Recruiting
Phase:
Phase 1/Phase 2
Trial Eligibility
Document
Title
- Brief Title: SEL24/MEN1703 in Patients With Acute Myeloid Leukemia
- 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
| Drug | Synonyms | Arms |
|---|---|---|
| SEL24/MEN1703 | SEL24-B489, MEN1703 | SEL24/MEN1703 |
Purpose
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.
Detailed Description
Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated
dose of SEL24/MEN1703 in patients with Acute Myeloid Leukemia.
The clinical trial will investigate the safety profile and anti-leukemic activity of
SEL24/MEN1703 in patients with Acute Myeloid Leukemia and that have no standard therapeutic
options available.
The clinical trial encompasses two parts:
- Part 1, ascending dose levels: the main purpose of this part of the clinical trial is to
determine the highest dose of SEL24/MEN1703 considered to be well tolerated.
- Part 2: Expansion cohort: the main purpose of this part of the clinical trial is to
assess the safety and anti-leukemia activity of SEL24/MEN1703 given at the highest
tolerated dose in patient with relapsed/refractory Acute Myeloid Leukemia, either all
comers as well as harboring IDH1/IDH2 mutations.
Patients participating to the clinical trial will take the study drug as oral capsules once
daily for 14 consecutive days over a 21-day treatment cycle.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| SEL24/MEN1703 | Experimental | SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. Part 1: ascending dose levels (cohort) will be tested in at least 3 patients. Any cohort in which 1 patient experiences a dose-limiting toxicity will be expanded up to 6 patients. Part 2: testing at the dose of SEL24/MEN1703 which have demonstrated to be adequately tolerated in Part 1. |
|
Eligibility Criteria
Inclusion Criteria:
- patients with diagnosis of Acute Myeloid Leukemia, all comers (completed) and bearing
IDH1 or IDH2 mutation (open for recruitment)
- Patient has no standard therapeutic options available and has either Relapsed AML
unsuitable for intensive chemotherapy and not eligible for any approved targeted
therapy or Primary refractory AML unsuitable for intensive chemotherapy and not
eligible for any approved targeted therapy
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 |
Secondary Outcome Measures
| Measure: | Safety profile of single agent SEL24/MEN1703 |
| Time Frame: | From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days. |
| Safety Issue: | |
| Description: | Number and frequency of AEs |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Menarini Group |
Trial Keywords
- AML
- Relapsed/Refractory Acute Myeloid Leukemia
- IDH
Last Updated
September 1, 2021
