Clinical Trial

Cisplatin Combined with Oral TS-1 in Patients with Advanced Solid Tumors with Different Degrees of Liver Dysfunction

Active, Not Recruiting Phase 2
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Summary
The purpose of this study is to formally characterize the pharmacokinetics (PK), safety, and tolerability of TS-1 in combination with cisplatin in adult patients with advanced solid tumors who have mild, moderate or severe hepatic impairment relative to patients with normal hepatic function, as categorized by the United States National Cancer Institute organ dysfunction working group \[NCI-ODWG\] criteria for hepatic dysfunction.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2018-04-25; most recent amendment 2024-09-17.
Status change: Recruiting → Active, Not Recruiting 2024-09-17
Trial Details
NCT Number NCT03519074
Lead Sponsor National University Hospital, Singapore
Conditions Cancer, Liver Dysfunction
Enrollment 48 participants
Start Date 2016-07-22
Primary Completion 2024-09-01 (estimated)
Study Completion 2025-12-20 (estimated)
Updated on ClinicalTrials.gov 2024-09-19