ACTRN12612001245886招募中2 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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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 treatment with WBRT
- •- Subject must have adequate hematologic, renal, and hepatic function
- •- Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for a minimum of 90 days
- •following completion of therapy.
- •- Subject must be able to take oral medication
- •- Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent
排除标准
- •- Subject is diagnosed with brain metastases = 21 days prior to Treatment Day 1
- •- Subject received any prior form of cranial radiation and/or neurosurgery for their brain metastases
- •- Subject's last dose of anti-cancer therapy or investigational therapy was = 7 days prior to Treatment Day 1. Subjects may continue to receive Bisphosphonates,
- •steroids, such as inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids, and medroxyprogesterone during the study if started prior to
- •treatment with veliparib/placebo and WBRT
- •- Subject has a Karnofsky Performance Score (KPS) of < 70
- •- Subject has a GPA Score of = 1.0
- •- Subject has clinically significant dyspnea requiring supplemental oxygen therapy
- •- Subject has liver metastases
- •- Subject has more than 2 sites (organ systems) of metastases from NSCLC with the exception of the following:
- •Intra-cranial sites of metastases from NSCLC; Thoracic sites of metastases from NSCLC; and Bone metastases
- •- Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a MRI brain scan
- •- 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 metastases 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)
- •- Subject has a history of another active cancer within the past 5 years except: Cervical cancer in situ; In situ carcinoma of the bladder; Basal or squamous cell carcinoma of the skin; Or other cancer in situ that is considered cured
研究者
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