drugset / Trial / NCT05101551
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-02-23
- Primary completion
- 2027-04
- Completion
- 2027-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | 600 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | Intravenous |
| Subject | Talazoparib | Small molecule | 400 ug/m2 | Oral |
| Subject | Talazoparib | Small molecule | 600 ug/m2 | Oral |
| Subject | Topotecan | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 2 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 3 mg/m2 | Intravenous |
| Subject | Topotecan | Small molecule | 4 mg/m2 | Intravenous |