GA NCORP

NCORP Trials

SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

Status
Closed
Cancer Type
Leukemia
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03008187
Protocol IDs
CLI24-001 (primary)
NCI-2017-00611
Study Sponsor
Menarini Group

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.

Objectives

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.

Treatment Sites


Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
Northside Hospital Central Research Department
404-303-3355
www.northside.com

Study Coordinator:
Stacey Brown
404-780-7965

Doctors:

Asad Bashey MD, PhD
H. Kent Holland MD
Lawrence E. Morris, Jr. MD
Scott R. Solomon MD
Melhem Solh MD