Head and Neck Squamous Cell Carcinoma Clinical Trial
Official title:
A Phase I Study of Single Agent Talazoparib (BMN 673) in Advanced Cancer Patients With Hepatic and Renal Dysfunction
This phase I trial studies the side effects and best dose of talazoparib in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have spread to other places in the body (metastatic) and cannot be removed by surgery and liver or kidney dysfunction. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
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.
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