NCT02454842

Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) Patients

A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Rain Oncology Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 study is designed to evaluate the safety and activity of TH-4000 a hypoxia-activated prodrug, in patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.

Detailed description

A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy. Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Conditions

• Non-small Cell Lung Cancer
• NSCLC
• Non-squamous NSCLC

Interventions

Type	Name	Description
DRUG	TH-4000 (Tarloxotinib)	TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-01-01
• Completion: 2017-01-31
• First posted: 2015-05-27
• Last updated: 2023-01-12

Locations

12 sites across 2 countries: United States, Australia