drugset / Trial / NCT04207190

Talazoparib and Gemtuzumab Ozogamicin for the Treatment of CD33 Positive Relapsed or Refractory Acute Myeloid Leukemia

NCT04207190

Phase 1 Completed 24 enrolled Roswell Park Cancer Institute Pfizer · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I/Ib trial studies the side effects and best dose of talazoparib given together with gemtuzumab ozogamicin and to see how well they work in treating patients with CD33 positive acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Gemtuzumab ozogamicin is a protein (antibody) combined with a chemotherapy drug which specifically targets acute myeloid leukemia cells expressing a marker (CD33). Adding talazoparib to the gemtuzumab ozogamicin therapy may lead to an increased effectiveness in treatment.

Timeline

Start
2020-10-23
Primary completion
2024-05-26
Completion
2024-06-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemtuzumab Ozogamicin Monoclonal antibody Intravenous
Subject Talazoparib Small molecule Oral