©2022 Stanford Medicine
Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Not Recruiting
Trial ID: NCT02449681
Purpose
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.
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
Stanford Investigator(s)
A. Dimitrios Colevas, MD
Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)
Eligibility
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Confirmed squamous cell carcinoma (SCC) 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 epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI)
therapy for recurrent or metastatic Squamous Cell Carcinoma (e.g., oral EGFR TKIs such
as erlotinib, gefitinib, or afatinib)
- Family history of long corrected QT interval (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
Intervention(s):
drug: TH-4000 (Tarloxotinib)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061