NCT05101551

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

A Phase I Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination With Chemotherapy

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Norman J. Lacayo · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study. This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Talazoparib	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
DRUG	Topotecan	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
DRUG	Gemcitabine	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

Timeline

• Start date: 2023-02-23
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2021-11-01
• Last updated: 2025-05-29

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study