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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03008187
Other study ID # CLI24-001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 10, 2017
Est. completion date May 11, 2023

Study information

Verified date May 2023
Source Menarini Group
Contact n/a
Is FDA regulated No
Health authority
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 May 11, 2023
Est. primary completion date May 11, 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)

Study Design


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.
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