EUCTR2014-004269-26-NO进行中（未招募）1 期
iraparib and niraparib-bevacizumab combination against bevacizumab alone in Women with Homologous Recombination Deficient (HRD) platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.Part 1: AVANOVA1 - A phase I study to evaluate the safety and tolerability of bevacizumab-niraparib combination therapy and determine the Recommended Phase 2 Dose (RP2D) in Women with platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer.Part 2: AVANOVA2 - A three-arm, open-label, phase II randomized study to evaluate the efficacy of niraparib and/or niraparib-bevacizumab combination against bevacizumab alone in Women with HRD platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer. - AVANOVA
ordic Society of Gynaecological Oncology (NSGO)0 个研究点目标入组 132 人开始时间: 2016年5月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
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
- 性别
- All
入选标准
- •Study population
- •1. Recurrent platinum-sensitive epithelial ovarian, fallopian tube, or peritoneal cancer (platinum sensitivity defined as no recurrence within 6 months of last receipt of platinum/chemotherapy).
- •2. High-grade serious or high-grade endometrioid histology. Other histological types are allowed if documented BRCA mutation.
- •3. Patient consents to perform HRD test.
- •4. HRD test positive.
- •5. Prior line of therapy: Patients must have received platinum-containing therapy for primary disease.
- •o No limits on number of platinum-based therapies. Population of patients who has previously received = 3 lines of therapy for relapsed disease will be capped at 40%.
- •o Up to one non-platinum-based line of therapy in recurrent setting.
- •o Patients who are treated with bevacizumab just prior to entering in the trial must not have progressed under or within 3 months after bevacizumab.
- •Other inclusion criteria:
- •6. Histological confirmed ovarian, fallopian tube or peritoneal cancers
- •7. Patients must give informed consent
- •8. Patients may have undergone primary or interval debulking surgery
- •9. Patients may have received bevacizumab or other anti-angiogenic therapy
- •10. Patients must have disease that is measurable according to RECIST or assessable according to the GCIG CA-125 criteria
- •11. The patient agrees to complete PROs (QoL questionnaire) during study treatment AND at one additional time point 8 weeks following progression of disease
- •12. ECOG performance status 0-2
- •13. Adequate organ function
- •o Absolute neutrophil count (ANC) =1,5 x 109/L
- •o Platelets >100 x 109/L
- •o Hemoglobin = 9g/dl
- •o Serum creatinine =1.5x upper limit of normal (ULN) or calculated creatinine clearance =50mL/min using Cockcroft-Gault formula
- •o Total bilirubin =1.5x ULN
- •o Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5x ULN unless liver metastases are present, in which case they must be =5x ULN.
- •14. Able to take oral medications
- •15. Life expectancy of at least 12 weeks
- •16. Patients must be fit to receive niraparib and/or bevacizumab
- •17. Women of childbearing potential must use adequate birth control for the duration of study participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •1. Ovarian sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers and cancer types not mentioned in the inclusion criteria 2. Concurrent cancer therapy
- •3. Concurrent treatment with an investigational agent or participation in another clinical trial
- •4. Prior treatment with PARP inhibitors
- •5. Major injuries or surgery within the past 21 days prior to start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period
- •6. Previous malignant disease: patients are not eligible for the study if diagnosis, detection or treatment of invasive cancer (other than ovarian cancer; with the exception of basal or squamous cell carcinoma of the skin that was definitively treated) was detected within 2 years prior to randomization
- •7. Active infections or other serious underlying significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, in the Investigator’s judgment, makes the patient inappropriate for this study
- •8. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug
- •9. History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction
- •10. Known contraindications to PARP inhibitors or VEGF directed therapy
- •11. Known uncontrolled hypersensitivity to the investigational drugs
- •12. History of major thromboembolic event defined as:
- •? Uncontrolled pulmonary embolism (PE)
- •? Deep venous thrombosis (DVT)
- •? Other related conditions, though patients with stable therapeutic anticoagulation for more than three months prior randomization are eligible for this study
- •13. History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 3 months
- •14. History of clinically significant hemorrhage in the past 3 months
- •15. Uncontrolled and/or symptomatic CNS metastasis or leptomeningeal carcinomatosis (Dexamethasone/prednisone therapy will be allowed if administered as stable dose for at least one month prior randomization)
- •16. Significant cardiovascular diseases, including uncontrolled hypertension, clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure > NYHA III, severe peripheral vascular disease, QT prolongation >470 msec ,clinically significant pericardial effusion
- •17. Pregnancy or breastfeeding. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of contraception for the duration of the trial and for 3 months afterwards.
- •18. Radiographic evidence of cavitation or necrotic tumors with invasion of adjacent major blood vessels
- •19. Active or chronic hepatitis C and/or B infection
- •20. Persistence of clinically relevant therapy related toxicity from previous chemotherapy
- •21. Proteinuria as demonstrated by: (a) urine protein: creatinine (UPC) ratio >/= 1.0 at screening OR (b) urine dipstick for proteinuria >/=2+ (patients discovered to have >/=2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hr urine collection and must demonstrate 22. Patients must not have any known history of MDS
- •23. Patients must not have k
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