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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2022
• Main ID: NCT03519074
• Date of registration: 02/04/2018
• Prospective Registration: No
• Primary sponsor: National University Hospital, Singapore
• Public title: Cisplatin Combined With Oral TS-1 in Patients With Advanced Solid Tumors With Different Degrees of Liver Dysfunction
• Scientific title: Phase II Trial of Cisplatin Combined With Oral TS-1 in Patients With Advanced Solid Tumors With Different Degrees of Liver Dysfunction
• Date of first enrolment: July 22, 2016
• Target sample size: 48
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03519074
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Singapore

Contacts

• Name: Soo Chin Lee

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients must fulfill ALL the following inclusion criteria

- Age 18 years.

- Histologic or cytologic diagnosis of carcinoma, that is either refractory to standard
therapy or has no available therapies.

- Measurable disease using the RECIST v1.1 criteria

- ECOG performance 0 or 1.

- Estimated life expectancy of at least 12 weeks.

- Adequate bone marrow and renal function as follows:

Bone marrow: Absolute neutrophil count (ANC) 1.5 x 109/L Platelets 100 x 109/L Renal:
calculated creatinine clearance >60ml/minute Total bilirubin and AST/ALT as described in
Table 1

- Able to swallow pills

- Signed informed consent from patient or legal representative

- Patients with reproductive potential must use an approved contraceptive method if
appropriate (e.g., intrauterine device, birth control pills, or barrier device) during
and for three months after the study.

- Females with childbearing potential must have a negative serum pregnancy test within 7
days prior to study enrollment.

Exclusion Criteria:

Patients will be excluded from the study for any of the following reasons:

- Concurrent administration of any other tumor therapy, including cytotoxic
chemotherapy, hormonal therapy, and immunotherapy.

- Treatment of a small molecule targeted agents = 2 weeks prior to starting study
treatment

- Treatment within the last 30 days with any investigational drug.

- Radiotherapy =4 weeks prior to starting study treatment or who have not recovered from
radiotherapy-related toxicities. Limited field palliative radiotherapy = 2 weeks prior
to starting study treatment is allowed

- Major surgery within 28 days of study drug administration.

- History or presence of serious uncontrolled ventricular arrhythmias

- Impairment of gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of TS-1 (e.g., ulcerative diseases, uncontrolled nausea,
vomiting, diarrhea, malabsorption syndrome, or small bowel resection)

- Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not
mandatory)

- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy.

- Pregnancy.

- Breast feeding.

- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the
investigator.

- Poorly controlled diabetes mellitus.

- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment

- Symptomatic brain metastasis.

- History of significant neurological or mental disorder, including seizures or
dementia.



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Cancer

Liver Dysfunction

Intervention(s)

Drug: TS-1 combined with cisplatin

Primary Outcome(s)

Efficacy evaluations: Disease status [Time Frame: Radiological evaluation of tumor status every 2 cycles of cisplatin and oral TS-1 from baseline until documented disease progression; assessed up to 12 months]

Efficacy Evaluation: Timing [Time Frame: 5 years]

Secondary ID(s)

2016/00691

Source(s) of Monetary Support

Please refer to primary and secondary sponsors