MEN1703 (SEL24) in Participants With Acute Myeloid Leukemia (Diamond-01)

Menarini

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Myeloid Leukemia

Treatments: Drug: MEN1703

Study type: Interventional

Funder types: Industry

Identifiers

NCT03008187

CLI24-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with diagnosis of AML, all comers or bearing IDH1 or IDH2 mutation (completed)
• Participant has no standard therapeutic options available and has either relapsed AML unsuitable for intensive chemotherapy, with no standard therapeutic options and/or not eligible for any approved targeted therapy or primary refractory AML unsuitable for intensive chemotherapy, with no standard therapeutic options and/or 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 6 patient groups

Cohort 1 (25 mg)

Experimental group

Description:

Participants received MEN1703 (25 milligrams \[mg\]) orally once daily for 14 consecutive days in cycles of 21 days.

Treatment:

Drug: MEN1703

Cohort 2 (50 mg)

Experimental group

Description:

Participants received MEN1703 (50 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Treatment:

Drug: MEN1703

Cohort 3 (75 mg)

Experimental group

Description:

Participants received MEN1703 (75 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Treatment:

Drug: MEN1703

Cohort 4 (100 mg)

Experimental group

Description:

Participants received MEN1703 (100 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Treatment:

Drug: MEN1703

Cohort 5 (125 mg)

Experimental group

Description:

Participants received MEN1703 (125 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Treatment:

Drug: MEN1703

Cohort 6 (150 mg)

Experimental group

Description:

Participants received MEN1703 (150 mg) orally once daily for 14 consecutive days in cycles of 21 days.

Treatment:

Drug: MEN1703