Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Threshold Pharmaceuticals

Stanford Investigator(s):


  • Drug: TH-4000


Phase 2


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

   - 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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting