The tear and plasma pharmacokinetics study of TS-1 monotherapy for gastric cancer patients.

The tear and plasma pharmacokinetics study of TS-1 monotherapy for gastric cancer patients. - The TS-1 tear study-01

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000021610

Enrollment

Registered

2016-04-04

Start date

2016-04-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

Tears collection and blood sumpling for pharmacokinetics

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.There is no treatment history of TS-1, gastric cancer patients to receive the first TS-1 therapy. 2.Cases of treatment of TS-1 is likely to be continued 1 course. 3.Creatinine clearance 60mL / min or more of the cases. 4.Cases of cases of age is below 80 years of age or 20 years of age at the time of registration. 5.After the start of treatment, it has been desired or consent hospitalization of a total of four days cases. 6.Cases of consent in writing has been obtained.

Exclusion criteria

Exclusion criteria: 1.Patients with metachronous double cancer / multiple cancer. 2.Patients with a history, complications of diseases of the eye, patients wearing contact lenses, dry eye cases, lacrimation Grade2 or more of the cases 3.Patients with sinusitis, patients with a nose trauma. 4.Other fluoropyrimidine anti-tumor agent flucytosine. 5.continued use is required cases of phenytoin and warfarin potassium Patients. 6.Patients with a history of Grade 3 or more of severe drug allergy. 7.Cases with serious complications 8.Cases of diarrhea can not be controlled by symptomatic therapy. 9.Cases of HBs antigen-positive or HCV antibody-positive. 10.Women who may have been pregnant or nursing women, pregnancy, women with intention of pregnancy. 11.Man who are willing to be pregnant 12.Other, investigator or sub-investigator has determined to be inappropriate as a subject of the present study case.

Design outcomes

Primary

Measure	Time frame
For patients TS-1 single-agent therapy is performed as unresectable recurrent gastric cancer or gastric cancer adjuvant chemotherapy, TS-1 oral administration on day 1 and day 14 in each 0,1,2,4,6, do the tear fluid collection and plasma pharmacokinetics in a total of 12 points after 8 hours, each of the measurement object compound, tegafur (FT), the pharmacokinetic parameters for 5-fluorouracil (5-FU) and gimeracil (CDHP) calculated for each subject, the average value of each scheduled sampling time, standard deviation, to calculate summary statistics such as the coefficient of variation, to examine the correlation between the concentration of the compound in the PK and tear.	—

Measure

Time frame

For patients TS-1 single-agent therapy is performed as unresectable recurrent gastric cancer or gastric cancer adjuvant chemotherapy, TS-1 oral administration on day 1 and day 14 in each 0,1,2,4,6, do the tear fluid collection and plasma pharmacokinetics in a total of 12 points after 8 hours, each of the measurement object compound, tegafur (FT), the pharmacokinetic parameters for 5-fluorouracil (5-FU) and gimeracil (CDHP) calculated for each subject, the average value of each scheduled sampling time, standard deviation, to calculate summary statistics such as the coefficient of variation, to examine the correlation between the concentration of the compound in the PK and tear.

—

Countries

Japan

Contacts

Public ContactTakeshi Kawakami

Shizuoka Cancer Center Division of Gastrointestinal oncology

t.kawakami@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026