Spots Global Cancer Trial Database for Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer
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Trial Identification
Brief Title: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer
Official Title: Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Patients With Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent
Study ID: NCT02973763
Conditions
Interventions
Study Description
Brief Summary: Alflutinib Mesylate Tablets is a Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor which can efficient suppress the EGFR T790M drug-resistant mutation tumor cell in Xenograft mouse model. This study aims at local advanced or metastatic non-small cell lung cancer patients with T790M drug-resistant mutation.
Detailed Description: This is a Phase I study, to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AST2818 in patients with advanced non-small cell lung cancer who progressed on prior therapy with an epidermal growth factor receptor tyrosine kinase inhibitor agent. The tolerability of AST2818 20 mg/day - 240 mg/day in 14 subjects was observed. 7-days observation period for a single dose and 21-days observation period for multiple doses.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Shi YK
Affiliation:
Role: PRINCIPAL_INVESTIGATOR
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