A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

Nanjing Yoko Biomedical

Status and phase

Unknown

Phase 1

Conditions

Neoplasms

Treatments

Drug: tafetinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02717741

NanjingYoko

Details and patient eligibility

About

Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR).

This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients with histologically confirmed advanced solid malignancies.
ECOG score 0-1.
18-65 years old.
Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks.
Function of organs must meet the following requirements:
Neutrophil count ≥1500/ul;
AST and ALT≤1.5 times the upper limit of normal (ULN);
Total serum bilirubin≤1.5 times ULN;
Hemoglobin≥90g/L;
Platelet≥100000/ul;
The creatinine in the normal range or creatinine clearance rate ≥60ml/min;
Left ventricular ejection fraction (LVEF) ≥50%;
Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study.
Written informed consent is obtained.