NCT02449681

Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

A Phase 2 Study of Tarloxotinib (TH-4000) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (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 participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

Detailed description

An open label, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.

Conditions

• Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions

Type	Name	Description
DRUG	TH-4000 (Tarloxotinib)

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-01
• Completion: 2017-01-31
• First posted: 2015-05-20
• Last updated: 2023-01-12

Locations

10 sites across 2 countries: United States, Australia