Spots Global Cancer Trial Database for Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin

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Trial Identification

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

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

Study ID: NCT02449681

Conditions

Metastatic Head-and-neck Squamous-cell Carcinoma

Interventions

TH-4000 (Tarloxotinib)

Study Description

Brief 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.