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Clinical Trial 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.


Clinical Trial Description

Hepatic impairment is a common co-morbidity in cancer patients, particularly in those with extensive liver metastases. Decreased drug clearance as a result of impaired liver function may lead to increased systemic exposure and possibly greater toxicity. As many chemotherapeutic agents are metabolized by the liver, treatment options tend to be limited in patients with severe hepatic impairment, even in the presence of good performance status and adequate other organ function. Cisplatin is an active chemotherapeutic agent with broad spectrum activity that can safely be administered in severe hepatic impairment. Cisplatin has been combined safely with full dose oral TS-1 with good efficacy in a spectrum of solid tumors in patients with adequate renal and hepatic function.

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03519074
Study type Interventional
Source National University Hospital, Singapore
Contact Soo Chin Lee
Phone (65) 6779 5555
Email soo_chin_lee@nuhs.edu.sg
Status Recruiting
Phase Phase 2
Start date July 22, 2016
Completion date December 20, 2025

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