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

NCT03519074 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • National University Hospital, Singapore

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-22
Primary Completion
2024-09-01
Completion
2025-12-20

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03519074 on ClinicalTrials.gov