An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)

Official Title

A Phase I Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800) in Patients With Advanced Solid Tumors and Normal or Varying Degrees of Hepatic Impairment

Summary:

This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in patients with advanced solid tumors and impaired hepatic function.

Trial Description

Primary Outcome Measures:

• Pharmacokinetics of talazoparib as assessed by trough plasma concentrations
  

• Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, Serious Adverse Event (SAE), AE related to study drug, SAE related to study drug.
  

At the end of the study, patients with no clinically significant toxicities, no contraindications to continue treatment with talazoparib, and no disease progression (underlying cancer progression) may be eligible to continue talazoparib treatment in a separate open-label extension study. The decision to allow the patient to continue dosing with talazoparib in an open-label extension (OLE) study will be based on potential overall benefit-risk and patient meeting eligibility criteria for OLE.

View this trial on ClinicalTrials.gov