Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
Stopped early · Phase 2
Conditions studied: Metastatic Head-and-neck Squamous-cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT02449681
- Run by
- Rain Oncology Inc
- People needed
- 30
- Starts
- 2015-08-01
- Expected to finish
- 2017-01-31
- Last updated by the study team
- 2023-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Southern California-Norris — Los Angeles, California, United States
- Stanford school of Medicine — Stanford, California, United States
- Georgetown Medical Center — Washington D.C., District of Columbia, United States
- University of Chicago — Chicago, Illinois, United States
- Walter Reed National Military Cancer Center — Bethesda, Maryland, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Vanderbilt-Ingram Cancer Center (VICC) — Nashville, Tennessee, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
- Peter MacCallum — East Melbourne, Victoria, Australia
Full record on ClinicalTrials.gov
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