Trials / Completed
CompletedNCT03008187
MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia
A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Menarini Group · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the clinical trial is to identify the maximum tolerated dose of MEN1703 and to further investigate its safety profile in participants with acute myeloid leukemia (AML).
Detailed description
Phase I/II, open-label, multi-center, dose escalation study to estimate the maximum tolerated dose of MEN1703 in participants with acute myeloid leukemia. The clinical trial will investigate the safety profile and anti-leukemic activity of MEN1703 in participants with AML and that have no standard therapeutic options available. The clinical trial encompasses 2 parts: * Part 1: Ascending dose levels - the main purpose of this part of the clinical trial is to determine the highest dose of 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 MEN1703 given at the highest tolerated dose in participant with relapsed/refractory acute myeloid leukemia, either all comers as well as harboring isocitrate dehydrogenase (IDH1/IDH2) mutations. Participants 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MEN1703 | MEN1703 given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle. |
Timeline
- Start date
- 2017-03-10
- Primary completion
- 2023-04-13
- Completion
- 2023-04-13
- First posted
- 2017-01-02
- Last updated
- 2025-04-29
- Results posted
- 2025-04-29
Locations
15 sites across 4 countries: United States, Italy, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03008187. Inclusion in this directory is not an endorsement.