NCT02537444已完成2 期
A Phase 2 Proof-of-Concept Study of ACP-196 Alone and in Combination With Pembrolizumab in Subjects With Recurrent Ovarian Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of Participants With Overall Response
研究概览
简要总结
To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years of age.
- •Histologically confirmed ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
- •Progression of disease after the most recent anticancer treatment. At least 1 prior chemotherapy regimen must have included a taxane.
- •Platinum-sensitive ovarian cancer defined by recurrence or progression of disease > 6 AND < 24 months after completion of the most recent platinum-based therapy.
- •Measurable disease as defined by RECIST 1.
- •ECOG performance status of 0 or
- •Completion of all therapy for the treatment of cancer 2 weeks before the start of study therapy and recovered.
排除标准
- •Evidence of platinum-refractory ovarian cancer defined as recurrence or progression during the first 6 cycles of or < 6 months after the beginning of first-line platinum based chemotherapy.
- •Evidence of platinum-resistant ovarian cancer defined as recurrence or progression within 6 months after completing the most recent platinum-based therapy.
- •More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.
- •Prior malignancy (other than ovarian cancer), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years.
- •Breastfeeding and pregnant.
- •Known central nervous system metastases and/or carcinomatous meningitis.
- •Subjects with active cardiovascular disease not medically controlled or those who have had myocardial infarction in the past 6 months..
- •Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction.
研究组 & 干预措施
Regimen 1
Experimental
Drug: acalabrutinib monotherapy
干预措施: Acalabrutinib (Drug)
Regimen 2
Experimental
Drug: Combination of acalabrutinib and pembrolizumab
干预措施: acalabrutinib and pembrolizumab combination (Drug)
结局指标
主要结局
Number of Participants With Overall Response
时间窗: Every 12 weeks for up to 2 years.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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