NCT02973763

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Alflutinib in Advanced Non Small Cell Lung Cancer

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Alflutinib

Timeline

• Start date: 2016-12-30
• Primary completion: 2021-02-04
• Completion: 2023-08-01
• First posted: 2016-11-25
• Last updated: 2025-04-03