GA NCORP

NCORP Trials

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

Status
Active
Cancer Type
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
Selvita S.A.

Summary

Phase I / II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy.

Objectives

This is a Phase I/II, open-label, multi-center, dose escalation study to estimate the MTD (or MAD) of SEL24 in patients with AML. At the end of Part 1 an RD of SEL24 will be selected for further evaluation in Part 2. In Part 2 the safety and anti-leukemic activity of SEL24 will be further assessed in patients who are unfit to receive intensive chemotherapy. Part 1 will commence with an accelerated dose escalation design for the first 4 cohorts. The study will then follow a 3+3 design from Cohort 5 onwards in order to provide adequate PK profile data. In Part 1 the MTD is defined as the highest dose at which no more than 1 in up to 6 patients experience a DLT during Cycle 1. The dose escalation rules to be followed during Part 1 of the study are described in the study protocol. The highest SEL24 dose level considered to be well tolerated in 6 patients, and to have optimal PK and PD characteristics, will be called the RD and will be selected for further evaluation in Part 2. Part 2 will enroll patients at the RD identified in Part 1. The treatment groups in Part 2 will be opened for recruitment based on recommendation by the Investigators, Medical Monitor and Sponsor.

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