NCT03502850

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Locally Advanced and Metastatic Non Small Cell Lung Cancer

A Phase I/II Study to Assess the Safety,Tolerability, Pharmacokinetics and Anti-tumour Activity of ASK120067 in Patients With Locally Advanced or Metastatic T790M Mutation-positive Non-Small Cell Lung Cancer Who Have Progressed Following Prior Therapy With an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Agent

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 507 (estimated)
• Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

ASK120067 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.

Conditions

• Locally Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	ASK120067	patients take ASK120067 orally once per day at 40,80,160,240,320,480mg

Timeline

• Start date: 2017-11-30
• Primary completion: 2021-01-01
• Completion: 2021-08-01
• First posted: 2018-04-19
• Last updated: 2020-09-16

Locations

3 sites across 1 country: China