NCT03140670终止2 期
A Phase 2, Open Label Study of Rucaparib in Patients With Advanced Pancreatic Cancer and a Known Deleterious Germline or Somatic BRCA or PALB2 Mutation
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
- 46
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) at 6 Months (PFS6)
研究概览
简要总结
The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also known as CO-338) on subjects and on their pancreatic cancer.
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
- •Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma with locally advanced or metastatic disease
- •≥18 years of age.
- •Eastern Cooperative Oncology (ECOG) performance status of 0 to
- •Patients may have previously failed non-platinum containing therapy or may never have previously progressed on treatment.
- •Patients must be on treatment with platinum-based (cisplatin, oxaliplatin or carboplatin) treatment for locally advanced or metastatic pancreatic cancer and have received a minimum of 16 weeks of therapy without evidence of disease progression based on the investigator's opinion.
- •Discontinuation of the platinum component of the regimen for chemotherapy-related toxicity is permissible provided the patient has previously received at least 16 weeks of platinum-based therapy without evidence of disease progression ≤8 weeks after treatment with the platinum agent
- •Documented deleterious BRCA1/2 or PALB2 mutation (germline or somatic) as assessed by CLIA certified laboratory. Variants that are considered to be non-detrimental ("Variants of uncertain significance", "Variants of unknown significance", "Variant, favor polymorphism" or "benign polymorphism" etc) are not sufficient for study entry.
- •Measurable disease is not required for enrollment.
- •Adequate organ function confirmed by the following laboratory values obtained ≤7 days prior to the first day of rucaparib:
- •Absolute neutrophil count (ANC) ≥1.5 x 109/L
- •Platelets>100 x 109/L
- •Hemoglobin≥9g/dL
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 x upper limit of normal (ULN)
- •Total bilirubin ≤1.5 x ULN; if liver metastases or metabolic disorder such as Gilbert's syndrome, then ≤2.5 x ULN.
- •Serum creatinine ≤1.5 x ULN or estimated glomerular filtration rate (GFR) ≥45 mL/min using Cockcroft Gault formula.
- •Exclusion Criteria
- •Prior treatment with a PARP inhibitor
- •Patients who have demonstrated resistance to platinum agents (e.g. oxaliplatin, cisplatin) are not eligible to participate in this study
- •Clinical evidence of uncontrolled malabsorption and/or any other gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with the absorption of rucaparib
- •Acute infection requiring intravenous antibiotics, antiviral or antifungal agents during the 14 days prior to first dose of rucaparib
- •Symptomatic or untreated CNS metastases.
- •Expected life expectancy of <12 weeks as determined by the investigator.
- •For fertile patient (female able to become pregnant or male able to father a child), refusal to use effective contraception during the period of the trial and for 6 months after the last dose of rucaparib.
- •Received any systemic treatment for pancreatic cancer ≤14 days prior to first dose of rucaparib.
- •Non-study related minor surgical procedure ≤5 days, or major surgical procedure ≤21 days, prior to the first dose of rucaparib; in all cases, patients must be sufficiently recovered and stable before treatment administration.
- •Active drug or alcohol use or dependence that would interfere with study compliance.
- •Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study.
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Experimental
干预措施: RUCAPARIB (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) at 6 Months (PFS6)
时间窗: 6 months
Time from initiation of rucaparib until progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Only if absolute increase is equal to or greater than 5mm.
次要结局
- Overall Response Rate (ORR)(24 months)
- Toxicity at Least Possibly Related to Rucaparib(24 months)
- Disease Control Rate (DCR)(24 months)
- Overall Survival(24 months)
- Duration of Response (DOR)(24 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA MutationPancreatic Ductal AdenocarcinomaPancreatic CancerNCT02042378pharmaand GmbH19
已完成
2 期
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial CancerMetastatic Endometrial CancerNCT03617679University of Colorado, Denver79
已完成
2 期
A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic SignatureMetastatic Breast CancerNCT02505048UNICANCER41
终止
2 期
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)Fallopian Tube CancerHigh Grade Serous CarcinomaEndometrioid AdenocarcinomaEpithelial Ovarian CancerPrimary Peritoneal CarcinomaNCT03824704pharmaand GmbH1
已完成
1 期
Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)Metastatic Castration Resistant Prostate CancerNCT04179396pharmaand GmbH8