NCT04171700终止2 期
A Phase 2 Multicenter, Open-label Study of Rucaparib as Treatment for Solid Tumors Associated With Deleterious Mutations in Homologous Recombination Repair Genes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 83
- 试验地点
- 18
- 主要终点
- Best Overall Response Rate by Investigator
研究概览
简要总结
A Phase 2, open-label, single-arm trial to evaluate the response of rucaparib in participants with various solid tumors and with deleterious mutations in Homologous Recombination Repair (HRR) genes.
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
- •Unresectable, locally advanced or metastatic solid tumor and relapsed/progressive disease
- •Measurable disease per RECIST v1.1 or modified RECIST v1.1 and PCWG3 (for prostate cancer)
- •Have a deleterious mutation (germline or somatic) in BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B. Note: Breast cancer patients that are HER2 negative and have germline BRCA1 or BRCA2 mutations AND patients with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or metastatic castration-resistant prostate cancer with BRCA1 or BRCA2 mutations are ineligible for this trial.
- •At least one prior line of therapy extending overall survival or standard of care therapy for advanced disease. Note: Some tumor types have specific inclusion/exclusion criteria for previous treatments.
- •ECOG 0 or 1
- •Tumor tissue available for genomic analysis, or must be willing to have a biopsy if no archival tumor tissue available
- •Adequate organ function
- •Life expectancy of 4 months
排除标准
- •Active central nervous system brain metastases, leptomeningeal disease or primary tumor of CNS origin
- •Active second malignancy (Exceptions: Successfully treated malignancy with no active disease for 1 year, surgically cured and/or low-risk tumors, or patients receiving ongoing anticancer hormonal therapy for a previously treated cancer)
- •Pre-existing gastrointestinal disorders/conditions interfering with ingestion/absorption of rucaparib
- •Prior treatment with a PARP inhibitor
- •More than 3 prior lines of chemotherapy in the locally advanced/metastatic setting
- •History of myelodysplastic syndrome or acute myeloid leukemia
研究组 & 干预措施
Rucaparib
Experimental
Eligible participants will be enrolled in either Cohort A or Cohort B.
Cohort A: Up to 200 participants with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D.
Cohort B (Exploratory): Up to 20 participants with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
干预措施: Rucaparib (Drug)
结局指标
主要结局
Best Overall Response Rate by Investigator
时间窗: From first dose of study drug until disease progression (up to approximately 2 years)
Best overall response rate as assessed by the investigator by RECIST v1.1 (or by RECIST v1.1 and PCWG3 in participants with advanced prostate cancer).
次要结局
- Disease Control Rate(From first dose of study drug until disease progression (up to approximately 2 years))
- Overall Response Rate by Independent Radiology Review(From first dose of study drug until disease progression (up to approximately 2 years))
- Progression-free Survival(From first dose of study drug until disease progression (up to approximately 2 years))
- Number of Participants Experiencing Treatment-emergent Adverse Events(From first dose of study drug until disease progression (up to approximately 2 years))
- Duration of Response(From first dose of study drug until disease progression (up to approximately 2 years))
- Overall Survival(From first dose of study drug until disease progression (up to approximately 2 years))
- Steady State Minimum Concentration [Cmin](From first dose of study drug until disease progression (up to approximately 2 years))
研究者
研究点 (18)
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