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Talazoparib in Treating Patients With Advanced or Metastatic Solid Tumors That Cannot Be Removed by Surgery and Liver or Kidney Dysfunction

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Adenocarcinoma
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Estrogen Receptor Negative
  • Head and Neck Neoplasms
  • Head and Neck Squamous Cell Carcinoma
  • HER2/Neu Negative
  • Hormone-Resistant Prostate Cancer
  • Lung Neoplasms
  • Mesothelioma
  • Metastatic Pancreatic Adenocarcinoma
  • Ovarian Neoplasms
  • Progesterone Receptor Negative
  • Small Cell Lung Carcinoma
  • Solid Neoplasm
  • Stage III Mesothelioma
  • Stage IIIA Gastric Cancer
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA Small Cell Lung Carcinoma
  • Stage IIIB Gastric Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Small Cell Lung Carcinoma
  • Stage IIIC Gastric Cancer
  • Stage IIIC Ovarian Cancer
  • Stage IV Mesothelioma
  • Stage IV Non-Small Cell Lung Cancer
  • Stage IV Ovarian Cancer
  • Stage IV Small Cell Lung Carcinoma
  • Stomach Neoplasms
  • Triple-Negative Breast Carcinoma
Clinical Trial Details
NCT number NCT02567396
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Withdrawn
Phase Phase 1
Start date June 2016
View Details
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