A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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tafetinib

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

Group Type EXPERIMENTAL

tafetinib

Intervention Type DRUG

Interventions

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tafetinib

Intervention Type DRUG

Eligibility Criteria

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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.