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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 34 participants
Start Date 2023-02-23
Est. Completion 2026-03
Phase Phase 1

Sponsor

Norman J. Lacayo

1 total trials

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What the Registry Record Tells You About NCT05101551

The ClinicalTrials.gov registry entry for NCT05101551 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (71% lower). The listed sponsor is Norman J. Lacayo, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.