EUCTR2017-005018-76-BE进行中（未招募）1 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 - FUlvestrant in gynecological Cancers that are potentially Hormone Sensitive: the FUCHSia study
niversity Hospitals Leuven0 个研究点目标入组 200 人开始时间: 2018年10月5日最近更新:
适应症
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
- 200
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
- •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 (LGESS, LGAS without sarcomatous overgrowth and LGLMS), low-grade endometrial carcinomas, sex cord stromal tumors (granulosa cell tumors...) and low grade serous ovarian cancer
- •Measurable disease, according to RECIST v1.1 criteria, assessed by CT scans
- •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, see Appendix 4) and archival tissue (< 3 years old) available
- •Minimum 1 and maximum 2 prior lines of hormonal therapy (tamoxifen, progestins and/or aromatase inhibitors). Hormone treatments of less than 3 months are not considered as a line of treatment. Thus, patients with 1 or 2 previous lines can be included.
- •ECOG performance status: 0-2
- •Demonstrate adequate organ function: creatinine =1.5 X upper limit of normal (ULN), serum total bilirubin = 1.5 X ULN, AST (SGOT) and ALT (SGPT) < 5 X ULN
- •Post-menopausal status as defined by (i) age 60 or more, or (ii) age 45-59 and satisfying the following criteria: amenorrhea for at least 12 months and FSH in postmenopausal range, or (iii) = 18 years of age and having had a bilateral oophorectomy
- •Be willing to receive 18F-FES PET scan. Exceptions will be made in case of (i) patients living far from one of the imaging centers and for whom travelling would be a too high burden for their physical conditions; (ii) patients who received tamoxifen within 8 weeks prior to study Day 1. These patients will be enrolled, but they will not receive a FES PET scan
- •Be willing to donate a core tumor biopsy if technically feasible
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
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 agent
- •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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