A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02717741
• Other study ID #: NanjingYoko
• Status: Recruiting
• Phase: Phase 1
• First received: March 3, 2016
• Last updated: March 23, 2016
• Start date: May 2015
• Est. completion date: April 2017

Study information

• Verified date: March 2016
• Source: Nanjing Yoko Biomedical Co., Ltd.
• Contact: Zhou s Yu, dr.
• Phone: 86-10-87788293
• Email: typhoonwho[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• tafetinib

Locations

Country	Name	City	State
China	Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Yoko Biomedical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity	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.	3 weeks	Yes