RecruitingPhase 1NCT05101551

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

Sponsor

Norman J. Lacayo

Enrollment

34 participants

Start Date

Feb 23, 2023

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

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.

Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing talazoparib — a drug that interferes with cancer cells' ability to repair their DNA — combined with chemotherapy in children and young adults (up to 21 years old) whose leukemia has returned or is not responding to treatment. **You may be eligible if...** - You are 21 years old or younger - You have acute myeloid leukemia (AML) or a related acute leukemia that has relapsed or did not respond to at least 2 courses of standard chemotherapy - Lab tests confirm leukemia cells are still present in your bone marrow **You may NOT be eligible if...** - You are over 21 years of age - You have an active serious infection or significant organ dysfunction - You are pregnant or breastfeeding - Your organ function does not meet the required minimums for safe treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTalazoparib

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

DRUGTopotecan

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

DRUGGemcitabine

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