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

Advanced Solid Tumors Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02997176
Study type Interventional
Source Pfizer
Contact
Status Completed
Phase Phase 1
Start date September 30, 2016
Completion date February 12, 2020
View Details
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