A Phase 2 Study of TH-4000 (Tarloxotinib) in Patients With EGFR-Mutant, T790M-Negative, Advanced Non-Small Cell Lung Cancer Progressing on an EGFR Tyrosine Kinase Inhibitor
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 12
- 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 patients with EGFR-Mutant, T790M-Negative, Advanced NSCLC.
详细描述
A single arm open label multi-center Phase 2 study in which the pharmacokinetics, safety, tolerability and efficacy of TH-4000 will be assessed in patients with EGFR mutant, T790M negative advanced NSCLC. Patients must have demonstrated progression during EGFR TKI therapy.
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
- 未提供
排除标准
- •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 corrected QT interval (QTc) syndrome
- •Symptomatic central nervous system (CNS) lesions
- •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 (e.g., tuberculosis, viral hepatitis, human immunodeficiency virus [HIV]), recent (within 6 months) myocardial infarction or unstable angina, congestive heart failure, poorly-controlled hypertension or diabetes, concurrent active malignancy, or psychiatric condition that may interfere with the patient's ability to follow study procedures
- •Pregnant or breast-feeding
研究组 & 干预措施
TH-4000 (Tarloxotinib)
TH-4000 (Tarloxotinib), 150 mg/m2 will be administered by IV infusion 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
- Overall Survival (OS)(Approximately 12 months)
- Area under concentration-time curve (AUC)(Cycle 1 Day 1 predose and up to 24 hours post dose)
- Incidence of adverse events (AEs)(Up to 30 days after last dose)
- Type of adverse events (AEs)(Up to 30 days after last dose)
- Time to peak plasma concentration (Tmax)(Cycle 1 Day 1 predose and up to 24 hours post dose)
- QTc Interval(Screening, Cycle 1 Day 1, 8, 15 & 22, Day 1 of subsequent cycles)
- Progression-free survival (PFS)(Approximately 12 months)
- 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)
- Maximum plasma concentration (Cmax)(Cycle 1 Day 1 predose and up to 24 hours post dose)