EUCTR2017-000161-75-GB进行中（未招募）1 期
An international phase III randomised study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy - ICON9
niversity College London0 个研究点目标入组 618 人开始时间: 2017年10月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 618
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Histologically proven diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with second-line platinum-based chemotherapy. Patients may be included post-surgery for relapsed disease if undertaken more than 6 months after progression from first-line therapy.
- •2.Patients must have had CT or MRI proven relapsed disease (measureable by RECIST 1.1 or non-measureable abnormalities supported by GCIG CA125 criteria of progression), or have had debulking surgery for first relapse.
- •3.Patients showing response to chemotherapy mid-treatment (post 3 or 4 cycles), either by GCIG CA125 criteria or ‘partial response’ on CT/MRI scan, or no evidence of progression having undergone surgical debulking, should be approached for ICON9 trial registration to allow for BRCA mutation status to be assessed (germline and/or somatic).
- •4.Completed a minimum of 4 cycles (and maximum of 6 cycles) of platinum-based chemotherapy for first relapse (2nd line treatment) with at least a partial response on imaging (CT or MRI) by RECIST 1.1 if measureable disease, or CA125 response by GCIG criteria if non-measurable disease. No CT/MRI or CA125 evidence of progression after surgical debulking and chemotherapy (above).
- •5.Prior front-line maintenance therapy with bevacizumab is permitted.
- •6.ECOG performance status 0-1.
- •7.Adequate bone marrow function, liver and renal function.
- •8.Availability of archival diagnostic tumour sample or tumour samples at relapse if patient has undergone further biopsy or surgical debulking.
- •9.Adequately controlled blood pressure (systolic blood pressure [SBP] =140 mmHg; diastolic blood pressure [DBP] = 90mmHg) on maximum of 3 antihypertensive medications.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 168
排除标准
- •1.Non-epithelial ovarian cancer, carcinosarcoma and mucinous carcinomas, ovarian clear-cell carcinoma.
- •2.Cerebrovascular accident (including transient ischemic attacks) within last 12 months.
- •3.Gastrointestinal impairment that could affect ability to take, or absorb oral medicines including sub-acute or complete bowel obstruction.
- •4.Symptomatic or clinically significant inflammatory bowel disease (Crohn’s disease or ulcerative colitis.
- •5.Evidence of severe or uncontrolled cardiac disease.
- •6.Evidence of active bleeding or bleeding diathesis.
- •7. Previous treatment with VEGFR tyrosine kinase inhibitors or PARP inhibitors are not permitted.
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