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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 3, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMarch 24, 2016
March 1, 2016
1.9 years
March 3, 2016
March 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
tafetinib
EXPERIMENTALtafetinib administered daily for 2 weeks, followed by a 1-week off period
Interventions
Eligibility Criteria
You may qualify if:
- Adult patients with histologically confirmed advanced solid malignancies.
- ECOG score 0-1.
- 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.
You may not qualify if:
- included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Interventions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2016
First Posted
March 24, 2016
Study Start
May 1, 2015
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
March 24, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share