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A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

Metastatic Solid Tumor Clinical Trial

Official title:
A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients

Clinical Trial Summary

This is a Phase 1 study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib in patients with advanced cancer.

Clinical Trial Description

This is a Phase 1, multicenter, multiple-dose, open-label, nonrandomized study to evaluate the effect of moderate or severe hepatic impairment on the PK of repotrectinib following single and multiple dose administration of repotrectinib in patients with advanced cancer. This study will enroll 8 patients each with moderate hepatic impairment, severe hepatic impairment and normal hepatic function. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05828277
Study type Interventional
Source Turning Point Therapeutics, Inc.
Contact
Status Withdrawn
Phase Phase 1
Start date July 28, 2022
Completion date December 31, 2025
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