A Double-blind, Randomized, Placebo-controlled Multicentre Phase II Study of Maintenance Enzastaurin Following Whole Brain Radiation Therapy in the Treatment of Brain Metastases From Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Time to Progression of Brain Metastases
研究概览
简要总结
This study is a multinational study to compare enzastaurin versus placebo in the treatment of patients with brain metastases of lung cancer. Approximately 108 patients will be randomly assigned to receive either enzastaurin or placebo after having completed whole brain radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Having radiologically proven brain metastases of lung cancer
- •Having received whole brain radiotherapy with either 30 grays in 2 weeks or 20 grays in one week. Treatment with enzastaurin must start within 14 days after the last fraction of the whole brain radiotherapy
- •No other previous radiotherapy to the brain except for radiosurgery at one occasion
- •Adequate organ function as measured by appropriate laboratory tests.
- •Age 18 years or older.
排除标准
- •Inability to swallow tablets or show conditions which could interfere with oral medication intake (e.g. vomiting, partial bowel obstruction).
- •Inability to discontinue use of certain anti-epileptic drugs such as, carbamazepine, phenobarbital or phenytoin.
- •Concurrent administration of warfarin
- •Hemophilia
- •Having had any systemic anti-cancer treatment within the last 2 weeks prior to enrolment.
研究组 & 干预措施
A
干预措施: enzastaurin (Drug)
B
干预措施: placebo (Drug)
结局指标
主要结局
Time to Progression of Brain Metastases
时间窗: Baseline to measured progressive disease (up to 21.2 months)
Time to progression (TTP) of brain metastases is the time from randomization to first observation of brain metastases progression. Response Evaluation Criteria In Solid Tumors (RECIST; Version 1.0), using magnetic resonance imaging (MRI), until observation of objective progression, or clinically as the date of increased steroids dose (barring radiological confirmation), was used to assess progressive disease (PD) of brain metastases. TTP was right-censored with the date of last contact if the participant died without MRI-documented PD or symptomatic deterioration or was lost to follow-up or received post therapy (Radio, Systemic, Surgery) before documented PD of the brain metastases.
次要结局
- Time to Objective Progression of Brain Metastases(Baseline to measured progressive disease (up to 21.2 months))
- Overall Survival(Baseline to date of death from any cause (up to 27.2 months))
- Best Overall Tumor Response on Brain Metastases by Percentage of Participants(Baseline to measured progressive disease (up to 21.2 months))
- Health-related Quality of Life (HRQoL) EORTC QLQ-C30 Physical Functioning(Baseline to 30 days after discontinuation (up to 17.6 months))
- HRQoL Questionnaire - EORTC QLQ-C30 Fatigue(Baseline to 30 days after discontinuation (up to 17.6 months))
- HRQoL Questionnaire - EORTC QLQ-C30 Diarrhea(Baseline to 30 days after discontinuation (up to 17.6 months))
- Overall Progression-free Survival (Including Both Progression of Brain and Extracranial Tumor Lesion)(Baseline to measured progressive disease (up to 14.4 months))
- Overall Response (OR) to Treatment of Extra-cranial Tumor Lesions by Percentage of Participants(Baseline to measured progressive disease (up to 27.2 months))
- HRQoL Questionnaire - EORTC QLQ-C30 Nausea/Vomiting(Baseline to 30 days after discontinuation (up to 17.6 months))
- HRQoL Questionnaire - QLQ-BN20 Headache(Baseline to 30 days after discontinuation (up to 17.6 months))
- Number of Participants With Adverse Events(every 6 weeks (up to 27.2 months))