EUCTR2019-001226-10-IT进行中（未招募）1 期
PHASE II PROSPECTIVE STUDY OF NIRAPARIB IN THE SALVAGE TREATMENT OF PATIENTS WITH METASTATIC/RECURRENT/PERSISTENT UTERINE CERVICAL CARCINOMA: PROOF OF CONCEPT (Translational substudy: Evaluation of molecular markers associated with Niraparib response) - NIRACERV
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE0 个研究点目标入组 42 人开始时间: 2020年10月7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
- 42
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
- Female
入选标准
- •Biopsy-proven diagnosis of cervical carcinoma was required, age >18 years and < 75 years, Eastern Cooperative Oncology Group (ECOG) performance status =2, presence of measurable disease, life expectancy >3 months, only 1 platinum based therapy (with or without bevacizumab) as first treatment of metastatic disease or recurrence or persistence of disease, absolute neutrophil count (ANC) >1,500/mm3; platelets count >100,000/ mm3; bilirubin and creatinine levels less than 1.5 times the upper limit of normal.
- •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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •Patients with recurrent disease were excluded if they were candidates for curative therapy by means of pelvic exenteration, previous or concomitant malignant disease (with the exception of cutaneous basalioma if adequately treated), active neurologic or psychiatric disease.
研究者
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