NCT03519074

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer
• Liver Dysfunction

Interventions

Type	Name	Description
DRUG	TS-1 combined with cisplatin	Cisplatin 60mg/m2, day 1, every 21 days Oral TS-1 30mg/m2 bd, days 1-14, every 21 days (absolute dose of oral TS-1 will be 40-60mg bd days 1-14, every 21 days, depending on body surface area)

Timeline

• Start date: 2016-07-22
• Primary completion: 2024-09-01
• Completion: 2025-12-20
• First posted: 2018-05-08
• Last updated: 2024-09-19

Locations

2 sites across 1 country: Singapore