Gopal, Ajay K, Popat, Rakesh, Mattison, Ryan J, Menne, Tobias, Bloor, Adrian, Gaymes, Terry, Khwaja, Asim, Juckett, Mark, Chen, Ying, Cotter, Matthew J and Mufti, Ghulam J (2021) A Phase I trial of talazoparib in patients with advanced hematologic malignancies. International Journal of Hematologic Oncology, 10(3), IJH35. ISSN (print) 2045-1393
Abstract
Aim: The objective of this study was to establish the maximum tolerated dose (MTD), safety, pharmacokinetics, and anti-leukemic activity of talazoparib. Patients & methods: This Phase I, two-cohort, dose-escalation trial evaluated talazoparib monotherapy in advanced hematologic malignancies (cohort 1: acute myeloid leukemia/myelodysplastic syndrome; cohort 2: chronic lymphocytic leukemia/mantle cell lymphoma). Results: Thirty-three (cohort 1: n = 25; cohort 2: n = 8) patients received talazoparib (0.1-2.0 mg once daily). The MTD was exceeded at 2.0 mg/day in cohort 1 and at 0.9 mg/day in cohort 2. Grade ≥3 adverse events were primarily hematologic. Eighteen (54.5%) patients reported stable disease. Conclusion: Talazoparib is relatively well tolerated in hematologic malignancies, with a similar MTD as in solid tumors, and shows preliminary anti leukemic activity.Clinical trial registration: NCT01399840 (ClinicalTrials.gov). Keywords: BRCA1/2 mutations; DNA damage response; hematologic malignancy; poly(ADP-ribose) polymerase inhibition; talazoparib.
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