PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
Objective
Primary Objectives: To determine a tolerable combination of talazoparib in combination with chemotherapy (topotecan plus gemcitabine) in pediatric subjects with relapsed or refractory acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage. Secondary Objectives: To measure PK of talazoparib in combination with topotecan and gemcitabine. To estimate the overall response rate to the combination of talazoparib with chemotherapy in pediatric subjects with relapsed or refractory AML.
