Trial | NCT02717741  Report issue

Title

A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor
A Phase I Study to Determine the Safety and Pharmacokinetic Study of Tafetinib in Patients With Advanced Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
Study Started
May 31
2015
Primary Completion
Apr 30
2017
Anticipated
Study Completion
Apr 30
2017
Anticipated
Last Update
Mar 24
2016
Estimate

Drug tafetinib

tafetinib Experimental

tafetinib administered daily for 2 weeks, followed by a 1-week off period

Criteria 

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.

Exclusion Criteria:

included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.
No Results Posted