NCT03607188

Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer

A Phase I Tolerance, Safety and Efficacy Study of Alkotinib in Patients With Advanced ALK Positive /ROS1 Positive NSCLC and Previously Treated With Chemotherapy or Crizotinib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.

Detailed description

The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below: 1. Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC. 2. Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib. 3. Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC. 4. Analysis the metabolites of ZG0418

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Alkotinib	Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD

Timeline

• Start date: 2018-10-18
• Primary completion: 2022-10-17
• Completion: 2022-10-17
• First posted: 2018-07-31
• Last updated: 2024-03-06

Locations

1 site across 1 country: China