Study for Treatment of Patients With Recurrent or Metastatic SCCHN or SCCS

• Status: Terminated
• Trial end date: 2017-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase 2 study is designed to evaluate the safety and activity of TH-4000 (Tarloxotinib), a hypoxia-activated prodrug in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Threshold Pharmaceuticals

Criteria

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Confirmed squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, or larynx) or skin

• For patients with oropharyngeal cancer, p16 status is known or can be determined

• Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

• Acceptable laboratory results as indicated by protocol

• Acceptable cardiac function as indicated by protocol

Exclusion Criteria:

• Received prior EGFR TKI therapy for recurrent or metastatic SCC (e.g., oral EGFR TKIs such as erlotinib, gefitinib, or afatinib)

• Family history of long QTc syndrome

• Receiving medication that prolongs QT interval ,with a risk of causing Torsades de Pointes (TdP), unless ECG meets inclusion criteria while on a stable dose of the medication

• Family history of long QTc syndrome

• Symptomatic central nervous system (CNS) lesions, or CNS lesions that require therapy

• Radiation therapy within 2 weeks prior to the first dose of study medication

• Major surgery within 4 weeks or minor surgery within 2 weeks prior to the first dose of study medication

• Concurrent active malignancy requiring systemic treatment

• Any other serious uncontrolled medical disorders or psychological conditions that may interfere with study conduct including but not limited to: clinically significant active infection

• Pregnant or breast-feeding