A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

Phase 1

• Conditions: Neoplasms
• Interventions: Drug: tafetinib

• Registration Number: NCT02717741
• Lead Sponsor: Nanjing Yoko Biomedical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Status Verified: 2016-03
• Study First Submitted: 2016-03-03
• Study First Submitted QC: 2016-03-23
• Last Update Submitted: 2016-03-23
• Study First Posted: 2016-03-24
• Last Update Posted: 2016-03-24
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	3 weeks	Dose-limiting toxicity was defined as any one of the following (NCI-CTCAE Version 4.0): (a) hypertension: uncontrollable grade 3 hypertensive or grade 4. (b) reduced LVEF: 2 degrees or above. (c) neutropenia : 3 degrees or above. (d) thrombopenia: 3 degrees or above. (e) Other Non-hematologic toxicity (not including alopecia, nausea or vomiting): 3 degrees or above.

Trial Locations

Locations (1)

Hospital; 🇨🇳 Beijing, Beijing, China