An Open-Label Clinical Trial of MORAb-009 in Combination With Pemetrexed and Cisplatin in Subjects With Mesothelioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Morphotek
- 入组人数
- 89
- 试验地点
- 28
- 主要终点
- Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
研究概览
简要总结
This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.
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
- •Confirmed diagnosis of malignant pleural mesothelioma (MPM) with the following characteristics: unresectable disease (or otherwise not a candidate for curative surgery); epithelial type or biphasic (mixed) type with low sarcomatous content.
- •Measurable disease at Screening by computed tomography (CT)(or magnetic resonance imaging [MRI]).
- •KPS of greater than or equal to 70% at Screening.
- •Life expectancy of at least 3 months
排除标准
- •Sarcomatous type of mesothelioma
- •Prior systemic therapy or radiotherapy for MPM; local radiotherapy for symptom control (ie, non-curative intent) is permitted.
- •Confirmed presence of CNS tumor involvement.
- •Evidence of other active malignancy requiring treatment.
研究组 & 干预措施
Open Label
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
干预措施: MORAb-009 (Amatuximab) (Drug)
Open Label
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
干预措施: Pemetrexed (Drug)
Open Label
Pemetrexed, Cisplatin and MORAb-009 (Amatuximab)
干预措施: Cisplatin (Drug)
结局指标
主要结局
Number of Participants With Progression Free Survival (PFS) Responders and Non-responders at Month 6
时间窗: Month 6
Number of participants with PFS responders and non-responders at Month 6 was reported. PFS was defined as the time from the date of the first dose of amatuximab to the date of disease progression or death due to any cause, as determined by independent radiologist based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) utilizing the total tumor measurement (performed by computerized tomography (CT)/magnetic resonance imaging (MRI)) which includes the pleural unidimensional measure plus the total of the target lesion(s) measurement. A "response", in terms of PFS, was defined to be at least a 6-month stabilization of disease. Progressive disease (PD) as measured by Modified RECIST was defined as an increase of at least 20 percent (%) in the total tumor measurement over the nadir measurement, or the appearance of one or more new lesions.
次要结局
- Time to Tumor Response (TTR)(From the date of the first dose to first documentation of objective response, up to approximately 5 years)
- Overall Survival (OS)(From the date of first dose to the date of death, up to approximately 5 years)
- Overall Response Rate (ORR)(From the date of first dose until evidence of CR or PR, up to approximately 5 years)
- Duration of Response (DR)(From the first documentation of objective response (CR or PR) to the first documentation of disease progression, up to approximately 5 years)
- Overall Progression Free Survival(From the date of first dose of amatuximab to the date of disease progression, up to approximately 5 years)