JPRN-UMIN000026475已完成3 期
A Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer - NRG-GY004
RG Oncology Group0 个研究点目标入组 578 人开始时间: 2017年3月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 578
研究概览
简要总结
npublished
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •Patients who have had chemotherapy or radiotherapy within 4 weeks of starting treatment prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, or had hormonal therapy within 2 weeks prior to entering the study. Patients may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks, nor receiving any medication that may markedly affect renal function, nor have received prior treatment affecting the VEGF pathway, nor have previously received a PARP inhibitor. Patients with untreated brain metastases, spinal cord compression, or evidence of symptomatic brain metastases or leptomeningeal disease as noted on CT or MRI scans. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cediranib or olaparib. Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. History of gastrointestinal perforation. History of intra-abdominal abscess within the past 3 months. Current signs and/or symptoms of bowel obstruction or signs. Dependency on IV hydration or TPN. Any concomitant or prior invasive malignancies with the following curatively treated exceptions. History of myocardial infarction within six months,Unstable angina,Resting ECG with clinically significant abnormal findings,NYHA classification of III or IV. History of stroke or transient ischemic attack within six months. Any prior history of hypertensive crisis or hypertensive encephalopathy. Clinically significant peripheral vascular disease or vascular disease. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting cediranib. Uncontrolled intercurrent illness. Pregnant women Known HIV-positive individuals. No prior allogeneic bone marrow transplant or double umbilical cord blood transplantation.
研究者
相似试验
进行中（未招募）
3 期
Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal CancerFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid TumorOvarian Seromucinous CarcinomaOvarian Serous TumorOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Ovarian Endometrioid AdenocarcinomaRecurrent Primary Peritoneal CarcinomaNCT02446600National Cancer Institute (NCI)579
已完成
3 期
Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer PatientsNon-Germline BRCA Mutated Ovarian CancerNCT03402841AstraZeneca279
进行中（未招募）
2 期
Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)Advanced Solid NeoplasmsNCT03742895Merck Sharp & Dohme LLC329
进行中（未招募）
2 期
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube CancerFallopian Tube CancerNeoadjuvant TreatmentOvarian CancerDebulking Surgical ProceduresNCT02489006University Health Network, Toronto71
已完成
1 期
The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.Advanced Solid TumoursNCT02430311AstraZeneca36