NL-OMON50189招募中2 期
An open-label, single arm, prospective, multi-center, tandem two stage designed, phase II study to evaluate the efficacy of Fulvestrant in women with recurrent/metastatic estrogen receptor positive gynecological malignancies - FUCHSia
Z Leuven0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Written informed consent prior admission to the study
- •Age >= 18 years at the moment of signing the informed consent
- •Recurrent or metastatic low grade uterine sarcomas, low-grade endometrial
- •carcinomas, sex cord stromal tumors and low grade serous ovarian cancer
- •Measurable disease, according to RECIST v1.1 criteria
- •ER-positive tumors based on immunohistochemistry, more than 10% of tumor cells
- •should be positive for ER. After the study, central analysis of ER staining
- •will be assessed using the Allred scoring system (based on intensity and
- •percentage of positive cells) and archival tissue (< 3 years old) available
- •1 or 2 prior lines of hormonal therapy
- •ECOG performance status: 0-2
- •Demonstrate adequate organ function
- •Post-menopausal status
- •Be willing to receive 18F-FES PET scan.
排除标准
- •Any other active malignancy or primary malignancy diagnosed within the
- •previous 5 years, except for adequately treated squamous or basal cell
- •carcinoma of the skin or in situ cervical carcinoma
- •Patients currently receiving (and unwilling to discontinue) any estrogen
- •replacement therapy.
- •Patients participating in a study or having participated in a study of an
- •investigational agent and received study therapy (or used an investigational
- •device) within 4 weeks prior to study Day 1
- •Patients who received prior chemo- or targeted therapy within 4 weeks prior
- •to study Day 1 or who has not recovered from adverse events (i.e., adverse
- •event not resolved to <= Grade 1 or baseline), due to a previously administered
- •Patients with no archival tissue available, except for patients from whom an
- •additional fresh core biopsy can be obtained for ER assessment
- •Any other disease, metabolic dysfunction, physical examination or clinical
- •laboratory finding that, in the investigator's opinion, gives reasonable
- •suspicion of a disease or condition that contraindicates the use of an
- •investigational drug, may affect the interpretation of the results, render the
- •patient at high risk from treatment complications or interfere with obtaining
- •informed consent.
- •Any condition not permitting compliance with the study protocol
研究者
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