NCT02959619

Ensartinib in Non-small Cell Lung Cancer Patients With Positive ALK

Phase 1, Dose-escalating, Open-label Study of Ensartinib, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is aimed to determine the maximum tolerated dose of ensartinib, an oral ALK inhibitor in Chinese patients with ALK-positive non-small cell lung cancer

Detailed description

The initial purpose of the study is to determine the largest amount of ensartinib that can be safely given to humans. An expansion phase will be conducted to assess the preliminary anti-tumor activity in ALK-positive non-small cell lung cancer once the recommended Phase 2 dose has been established.

Conditions

• Solid Tumor
• Non-Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Ensartinib	Oral ensartinib was given daily at escalating doses in a 28-day cycle

Timeline

• Start date: 2017-03-06
• Primary completion: 2019-10-31
• Completion: 2020-04-23
• First posted: 2016-11-09
• Last updated: 2023-08-21

Locations

1 site across 1 country: China