SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase I/II Study of SEL24 in Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008187
• Other study ID #: CLI24-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 10, 2017
• Est. completion date: April 13, 2023

Study information

• Verified date: May 2024
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 13, 2023
• Est. primary completion date: April 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• SEL24/MEN1703
SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.

Locations

Country	Name	City	State
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola
Italy	Istituto Clinico Humanitas	Milano
Italy	ASST Monza - Ospedale San Gerardo	Monza
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Hematologii z Pododdzialem Chemioterapi	Lódz
Poland	Institute of Haematology and Blood Transfusion	Warsaw
Spain	Institut Català d'Oncologia	Badalona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Universitari i Politecnic La Fe	Valencia
United States	Northside Hospital	Atlanta	Georgia
United States	Cleveland Clinic, Taussig Cancer Institute	Cleveland	Ohio
United States	Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Vanderbilt Ingram Cancer Center	Nashville	Tennessee
United States	Oregon Health and Science University	Portland	Oregon
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Menarini Group	Medpace, Inc., Theradex

Countries where clinical trial is conducted

United States,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT) evaluation	Maximum tolerated dose (MTD) or maximum administered dose (MAD) estimate	DLTs in patients during their first 21-day treatment cycle
Secondary	Safety profile of single agent SEL24/MEN1703	Number and frequency of AEs	From Cycle 1 Day 1 to Final Study Visit (up to 30 days after last administered dose). Each Cycle lasts 21 days.