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临床试验/ACTRN12618000498291
ACTRN12618000498291招募中3 期

International Phase III Randomised Study to Evaluate the Efficacy of Maintenance Therapy With Olaparib and Cediranib or Olaparib Alone in Patients With Relapsed Ovarian Cancer Following a Response to Platinum-based Chemotherapy.

The University of Sydney0 个研究点目标入组 110 人开始时间: 2018年4月6日最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
入组人数
110
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit（—）
性别
Female

入选标准

  • •Registration
  • •1. Provision of informed consent prior to any study specific procedures and the ability
  • •to comply with the protocol for the duration of the study, including undergoing
  • •treatment and scheduled visits and examinations.
  • •2. Females aged 18 years or older with previous histologically proven diagnosis of high grade serous or endometrioid carcinoma of the
  • •- Fallopian tube
  • •- or peritoneum,
  • •progressing 6 months or greater after day 1 of the last cycle of first-line platinum-based chemotherapy and requiring treatment with platinum-based chemotherapy on the basis of radiological evidence (RECIST v1.1) of disease or following surgical resection of recurrent disease.
  • •Patients may be included post-secondary surgery if undertaken 6 months or greater after day 1 of the last cycle of first-line platinum-based chemotherapy.
  • •3. 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.
  • •4. 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).
  • •5. Prior front-line maintenance therapy with bevacizumab is permitted.
  • •6. ECOG performance status 0-1.
  • •7. Formalin fixed, paraffin embedded (FFPE) tumour sample from the primary cancer or from secondary debulking surgery must be available for central testing. For inclusion in i)
  • •the genetic HRD Test and ii) the biomarker research, patients must complete the consent form.
  • •8. Patients must have a life expectancy of at least 16 weeks.
  • •9. Postmenopausal or evidence of non-childbearing status for women of childbearing potential: negative urine or serum pregnancy test within 28 days prior to study treatment and confirmed prior to treatment on day 1.
  • •Postmenopausal is defined as:
  • •- Amenorrheic for 1 year or more following cessation of exogenous hormonal
  • •- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the
  • •post-menopausal range for women under 50
  • •- Radiation-induced oophorectomy with last menses >1 year ago
  • •- Chemotherapy-induced menopause with >1 year interval since last menses
  • •- Or surgical sterilisation (bilateral oophorectomy or hysterectomy)
  • •10. Adequately controlled blood pressure (systolic blood pressure [SBP] equal to or less than 140 mmHg; diastolic blood pressure [DBP] equal to or less than 90mmHg) on maximum of 2 antihypertensive medications.
  • •11. Adequately controlled thyroid function, with no symptoms of thyroid dysfunction.
  • •Randomisation
  • •1. Patients must have received at least 4 cycles, and a maximum of 6 cycles of second-line platinum-based chemotherapy.
  • •2. In patients with measurable disease end of treatment scans must have a RECIST 1.1
  • •'partial response' or 'complete response' for randomisation to take place.
  • •3. In patients with non-measurable disease, who have not undergone debulking surgery,
  • •there must have been a GCIG CA125 response to chemotherapy.
  • •4. If CA125 has not normalised after chemotherapy then patients mu

排除标准

  • •1. Non-epithelial ovarian cancer, carcinosarcoma, clear cell carcinoma and mucinous carcinomas.
  • •2. Arterial thrombotic event (including transient ischaemic attack, cerebrovascular accident, and peripheral arterial embolus) within the last 12 months.
  • •3. Patients unable to swallow orally administered medication and patients with gastrointestinal impairment that could affect ability to take, or absorption of oral medicines including sub-acute or complete bowel obstruction.
  • •4. Clinically significant signs and/or symptoms of bowel obstruction within 3 months prior to starting treatment.
  • •5. History of intra-abdominal abscess within 3 months prior to starting treatment.
  • •6. History of GI perforation. Patients with a history of abdominal fistula will be considered eligible if the fistula was surgically repaired, there has been no evidence of fistula for at least 6 months prior to starting treatment, and patient is deemed to be at low risk of recurrent fistula.
  • •7. Symptomatic or clinically significant inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
  • •8. Patients with an ileostomy will be excluded.
  • •9. Evidence of severe or uncontrolled cardiac disease.
  • •a. Myocardial infarct or unstable angina within the last 6 months
  • •b. New York Health Association (NYHA) equal to or greater than grade 2 congestive heart failure
  • •c. Cardiac ventricular arrhythmias requiring medication
  • •d. History of 2nd or 3rd degree atrioventricular conduction defects
  • •10. Resting ECG with QTcF greater than 470msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.
  • •11. Evidence of active bleeding or bleeding diathesis.
  • •Significant haemorrhage of greater than 30ml in a single episode within the last 3 months or any haemoptysis (greater than 5ml fresh blood in last 4 weeks).
  • •12. Malignancy treated within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1, grade 1 endometrial carcinoma.
  • •13. Previous treatment with VEGFR tyrosine kinase inhibitors or PARP inhibitors are not permitted.
  • •14. Patients with a known hypersensitivity to excipients of cediranib or olaparib
  • •15. Persisting equal to or greater than grade 2 CTCAE toxicity (except alopecia and neuropathy) from previous anti-cancer treatment.
  • •16. Major surgery within 14 days before anticipated start of treatment and patients must have recovered from any effects of major surgery.
  • •17. Inability to attend or comply with treatment or follow-up scheduling.
  • •18. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicated the use of an investigation drug or puts the patients at high risk for treatment-related complications.
  • •19. Pregnant or breast-feeding women are excluded. Women of childbearing potential will be excluded unless effective methods of contraception are used from signing of the informed consent, throughout the period of taking study treatment and for at least 6 weeks after last dose of trial drug(s).
  • •20. Treatment with any other investigational agent, or participation in another interventional clinical trial within 28 days prior to enrolment.
  • •21. Concomitant use of known CYP3A4 inhibitors (such as ketoconazole, itraconazole, protease inhibitors boosted with ritonavir or cobicastat, indinavir, saquinavir, nelfin

研究者

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