drugset / Trial / NCT02274337

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Advanced Non Small Cell Lung Cancer

NCT02274337

NaSingle-groupOpen-labelTreatment

Summary

AC0010 Maleate Capsules is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor.Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the sigal signal transduction system of EGFR, and close the function of ras/raf/MAPK downstream. at last block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010 Maleate Capsules has three characters: 1. Irreversible combination with EGFR; 2.Efficient suppress the EGFR mutant tumor cell and has no suppression to EGFR wild-type cell; 3. Efficient suppress the EGFR T790M drug-resistant mutation tumor cell.

Timeline

Start
2014-09
Primary completion
2017-06
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Abivertinib Small molecule 50 mg Oral
Subject Abivertinib Small molecule 100 mg Oral
Subject Abivertinib Small molecule 200 mg Oral
Subject Abivertinib Small molecule 350 mg Oral
Subject Abivertinib Small molecule 550 mg Oral
Subject Abivertinib Small molecule 850 mg Oral
Subject Abivertinib Small molecule 1100 mg Oral