Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy

"Talazoparib will be administered in escalating doses based on current dose level.~* Dose Level 1: 400 µg/m2/dose once daily~* Dose Level 2: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5~* Dose Level 3: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5~* Dose Level 4: 600 µg/m2/dose BID on Day 1, then daily on Days 2 to 5~* Dose Level 5: 600 ug/m2/dose BID on Day 1, then daily on Days 2 to 5 and 15 to19"

"Administered IV route on Days 1 to 5~* Dose Level -2: 1 mg/m2/dose once daily by IV days 1 to 5~* Dose Level -1: 2 mg/m2/dose once daily by IV days 1 to 5~* Dose Level 1: 2 mg/m2/dose once daily by IV days 1 to 5~* Dose Level 2: 2 mg/m2/dose once daily by IV days 1 to 5~* Dose Level 3: 3 mg/m2/dose once daily by IV days 1 to 5~* Dose Level 4: 4 mg/m2/dose once daily by IV days 1 to 5~* Dose Level 5: 4 mg/m2/dose once daily by IV days 1 to 5"

"Single dose (IV) of gemcitabine on Day 1 of each 28 day cycle for 1 cycle.~* Dose Level -2: 600 mg/m2/dose once daily by IV days 1~* Dose Level -1: 600 mg/m2/dose once daily by IV days 1~* Dose Level 1: 1200 mg/m2/dose once daily by IV days 1~* Dose Level 2: 1200 mg/m2/dose once daily by IV days 1~* Dose Level 3: 1200 mg/m2/dose once daily by IV days 1~* Dose Level 4: 1200 mg/m2/dose once daily by IV days 1~* Dose Level 5: 1200 mg/m2/dose once daily by IV days 1"