A Study of CC-90002 in Subjects With Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome (MDS)
Status:
Terminated
Trial end date:
2018-07-18
Target enrollment:
Participant gender:
Summary
Study CC-90002-AML-001 is an open-label, Phase 1 dose escalation (Part A) and expansion (Part
B), clinical study of CC-90002, administered by intravenous (IV) infusion, in subjects with
relapsed and/or primary refractory AML and high-risk MDS. The study will explore escalating
doses of CC-90002 using a 3 + 3 dose escalation design in Part A, followed by dose expansion
in Part B.
The primary objective is to determine the safety and tolerability of CC-90002 and also to
define the non-tolerated dose (NTD), the maximum tolerated dose (MTD) and/or the recommended
Phase 2 dose (RP2D) of CC-90002.