A Study of RO6870810/TEN-010 in Participants With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Status:
Completed
Trial end date:
2017-08-09
Target enrollment:
Participant gender:
Summary
RO6870810 (formerly TEN-010) is a small molecule, bromodomain and extra-terminal (BET)
bromodomain inhibitor. This study is designed to characterize the safety, tolerability, and
pharmacokinetics of RO6870810 monotherapy in participants with relapsed/refractory acute
myeloid leukemia (RR-AML) and hypomethylating agent (HMA)-refractory myelodysplastic syndrome
(MDS). The study will consist of a Screening Period, Treatment Period, and Post-Treatment
Period. A standard 3+3 design will be used in which successive cohorts of three or more
participants with RR-AML or HMA-refractory MDS will be treated at escalating doses until a
maximum tolerated dose (MTD) is identiļ¬ed. Up to 51 adult participants with AML or MDS will
be enrolled in the study.