Clinical trial · Interventional
Study for Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
A Phase 2 Study of Tarloxotinib (TH-4000) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
NCT02449681CI-TRIAL-00063181terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Head-and-neck Squamous-cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TH-4000 (Tarloxotinib) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TH-4000 (Tarloxotinib)
- description
- TH-4000 150 mg/m2 will be administered by IV infusion over 60 minutes on Days 1, 8, 15 and 22 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.
- interventionNames
- Drug: TH-4000 (Tarloxotinib)
Primary outcomes (1)
- measure
- Number of participants with response rate as evaluated by RECIST criteria
- timeFrame
- Approximately 12 months
Secondary outcomes (9)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- Up to 30 days after last dose
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMcLean LS, Morris TA, Gramza A, Liu S, Khan SA, Colevas AD, Pearce T, Rischin D. A phase II study of tarloxotinib (a hypoxia activated prodrug of a pan-erb tyrosine kinase inhibitor) in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or skin. Invest New Drugs. 2022 Aug;40(4):782-788. doi: 10.1007/s10637-022-01230-w. Epub 2022 Apr 18. PMID 35435625