NCT03389815

A Study Evaluates the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients

The Dose-escalation Study Followed by an Extension Phase Evaluating the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients With Anaplastic Lymphoma Kinase（ALK）/Receptor Tyrosine Kinase（ROS1） Positive

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate safety, pharmacokinetics and efficacy of WX-0593 alone in the treatment of advanced cancer.

Detailed description

The first part is a single-arm, phase 1, open label, dose-escalation design in patients with anaplastic lymphoma kinase（ALK）/receptor tyrosine kinase（ROS1） Positive ALK/ROS1-positive solid tumor. The second part is an expansion in non-small cell lung Cancer (NSCLC) characterized by abnormalities in anaplastic lymphoma kinase(ALK) expression.

Conditions

• Advanced Solid Tumor, Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	WX-0593 Tablets	tablets, dosage ranged from 30 mg to 300 mg, quaque die（QD）

Timeline

• Start date: 2017-09-14
• Primary completion: 2020-06-01
• Completion: 2020-12-01
• First posted: 2018-01-04
• Last updated: 2018-01-04

Locations

1 site across 1 country: China