NCT02449681终止2 期
A Phase 2 Study of Tarloxotinib (TH-4000) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Skin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 10
- 主要终点
- Number of participants with response rate as evaluated by RECIST criteria
研究概览
简要总结
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.
详细描述
An open label, multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in participants with recurrent or metastatic squamous cell carcinoma of the head and neck or skin.
Hypoxia PET scans will be obtained in select centers to analyze potential predictors of tumor response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TH-4000 (Tarloxotinib)
Experimental
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.
干预措施: TH-4000 (Tarloxotinib) (Drug)
结局指标
主要结局
Number of participants with response rate as evaluated by RECIST criteria
时间窗: Approximately 12 months
次要结局
- QTc Interval(Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 and study Termination)
- Incidence of adverse events (AEs)(Up to 30 days after last dose)
- Severity of adverse events (AEs)(Up to 30 days after last dose)
- Duration of response (DOR) calculated for all patients achieving an objective response(Approximately 12 months)
- Progression-free survival (PFS)(Approximately 12 months)
- Maximum plasma concentration of TH-4000 (prodrug) and TH-4000E (TKI effector)(Cycle 1 Day 1 predose and up to 24 hours postdose)
- Type of adverse events (AEs)(Up to 30 days after last dose)
- Overall Survival (OS)(Approximately 12 months)
- Area under the plasma concentration versus time curve of TH4000 (prodrug) and TH-4000E (TKI effector)(Cycle 1 Day 1 predose and up to 24 hours postdose)
研究者
研究点 (10)
Loading locations...
相似试验
终止
2 期
Study for Treatment With TH-4000 (Tarloxotinib) in Epidermal Growth Factor Receptor (EGFR) Mutant, T790M-negative Non-small Cell Lung Cancer (NSCLC) PatientsNon-squamous NSCLCNon-small Cell Lung CancerNSCLCNCT02454842Rain Oncology Inc21
终止
2 期
Pilot Efficacy Study of T2000 in Myoclonus DystoniaMyoclonusNCT00506012Taro Pharmaceuticals USA5
终止
2 期
A Study of T2000 in Essential TremorEssential TremorNCT00321087Taro Pharmaceuticals USA10
终止
2 期
T2000 in Essential Tremor - Open Label ContinuationEssential TremorNCT00655278Taro Pharmaceuticals USA5
终止
2 期
Study of Induction of Hypothyroxinemia Adjunct to Conventional Therapies in GBM PatientsGlioblastoma Multiforme (GBM)NCT02654041Musli Thyropeutics Ltd.3