SEL24/MEN1703 in Patients With Acute Myeloid Leukemia

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT03008187
Trial Phases:	Phase I Phase II	Protocol IDs:	CLI24-001 (primary) NCI-2017-00611
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Menarini Group
NCI Full Details:	http://clinicaltrials.gov/show/NCT03008187

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 in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
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

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.