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NCT05101551 · ClinicalTrials.gov registry record · Phase 1
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Norman J. Lacayo.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 9
- Study locations
NCT05101551: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by Norman J. Lacayo.
NCT05101551 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Norman J. Lacayo. The registered enrollment target is 34 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (71% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05101551, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Norman J. Lacayo.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 9
- Study locations
Study 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.
Primary Outcome
Patient safety is assessed as dose limiting toxicity (DLT). The outcome is the number of DLT events. A DLT event is defined as: * Hematologic DLT - Failure to recover peripheral ANC to \> 200/µL or non-transfusion-dependent platelets to \> 20,000/µL by Day 43 from the start of Cycle 1 of chemotherapy will be considered a DLT, unless the delay in count recovery is due to another identifiable factor * Non-Hematologic DLT-Any ≥ Grade 4 non-hematological organ toxicity, including Hy's Law case is a
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Talazoparib
- DRUG Topotecan
Study Locations (9)
California
- City of Hope - Duarte
- Stanford University - Stanford
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Ohio
- Cincinnati Children's Hospital - Cincinnati
Pennsylvania
- Pennsylvania State University Hershey Medical Center - Hershey
Tennessee
- St. Jude Children's Research Hospital - Memphis
Utah
- University of Utah - Salt Lake City
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2023-02-23 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT05101551 shows while recruiting
NCT05101551 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Gemcitabine is the first listed.
NCT05101551 lists 9 locations in 8 states (California, Arizona, Arkansas).
Frequently Asked Questions
What is clinical trial NCT05101551 about?
NCT05101551 is a clinical study titled "Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy". 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 tol...
What is the current status of trial NCT05101551?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2023-02-23. Estimated completion is 2026-03.
What conditions does trial NCT05101551 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05101551?
The interventions under investigation include: Gemcitabine (DRUG), Talazoparib (DRUG), Topotecan (DRUG).
Who is sponsoring clinical trial NCT05101551?
This trial is sponsored by Norman J. Lacayo, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05101551 being conducted?
This trial has 9 study locations across Arizona, Arkansas, California, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05101551's enrollment target sits among peer trials
34 195th of 306 higher than 112 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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