Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
PRIMARY OBJECTIVES: I. To determine safety, tolerability and recommended phase 2 dose (RP2D) of talazoparib in patients with varying degrees of hepatic and renal dysfunction. SECONDARY OBJECTIVES: I. To observe preliminary antitumor activity of talazoparib in patients with cancers that commonly harbor defects in homologous recombination repair. II. To assess the pharmacokinetic (PK) profiles of talazoparib in patients with varying degrees of hepatic and renal dysfunction. III. To evaluate the pharmacodynamic (PD) effects of talazoparib. IV. To evaluate biomarkers associated with response or resistance to talazoparib. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 6 cohorts based on the degree of hepatic or renal dysfunction. Patients receive talazoparib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
