EUCTR2011-003618-18-NO进行中（未招募）1 期
A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects with Brain Metastases from Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 307
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subject must be = 18 years of age;
- •Subject must have cytologically or histologically confirmed NSCLC;
- •Subject must have brain metastases as demonstrated on a MRI brain scan;
- •Subject must be eligible for WBRT;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •Subject was diagnosed with brain metastasis =21 days prior to Treatment Day 1;
- •Subject received any prior form of cranial radiation and/or neurosurgery for brain metastasis;
- •Subject has a Karnofsky Performance Score (KPS) of < 70;
- •Subject has a GPA Score of = 1.0;
- •Subject has significant dyspnea requiring supplemental oxygen therapy;
- •Subject has liver metastases (restaging is not required for known liver metastasis);
- •Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following: intra-cranial sites of metastasis from NSCLC, thoracic sites of metastasis from NSCLC, and bone metastasis;
- •Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a baseline MRI brain scan;
- •Subject's last dose of chemotherapy or investigational therapy was = 7 days prior to Treatment Day 1;
- •Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment;
- •Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastasis are eligible however he/she should receive adequate anti-seizure medication prior to study treatment;
- •Subject is pregnant or lactating;
- •Subject has previously been treated with a PARP inhibitor as an investigational agent;
- •Subject has clinically significant and uncontrolled major medical condition(s)
研究者
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