EUCTR2019-001447-40-IT进行中（未招募）1 期
Pilot Study of Daily Exemestane in Women with Complex Atypical Hyperplasia of the Endometrium / Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer - UWI2016-08-01
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •-Females with a histologically proven CAH/ EIN or low grade (grade 1 or grade 2) endometrial carcinoma (EC) for which surgery is planned. The pathologic report from the referring facility will be used to determine pathologic eligibility. This report must be within 45 days of their baseline (pre-surgical) clinic visit.
- •-No prior treatment for CAH/EIN/EC
- •-Age =45 years
- •-Post-menopausal (= 60 years of age or with FSH >30 IU/L if age 45-59). The Ki-67 expression changes based on menopausal status and specifically varies based on what phase of the menstrual cycle the sample is collected. Therefore, in order to eliminate this source of variability, only postmenopausal women will be included in this trial. In addition, exemestane is currently FDA approved for use in post-menopausal women only.
- •-ECOG performance status =1 (appendix A)
- •-Participants must have normal organ and marrow function as defined below:
- •Hemoglobin = 9 g/dL
- •Serum creatinine = 1.5× upper limit of normal or calculated creatinine clearance = 60 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5× Institutional ULN
- •Total bilirubin = 1.5× ULN OR direct bilirubin = 1× ULN,
- •AST and ALT = 2.5× ULN
- •Hematologic function: WBC ¿ 3000/mcl; platelets ¿ 100,000/mcl.
- •-Able and willing to take oral medications.
- •-Ability to understand and the willingness to sign a written informed consent document.
- •-BMI > 20
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •-Participants who had curatively treated invasive malignancies for which all treatments ended within 1 year prior to the study (with the exception of basal cell or squamous cell carcinoma of the skin),
- •-Not a surgical candidate or surgery is not scheduled within 43 days from starting the study drug.
- •-Receiving any other investigational agents.
- •-Any gastrointestinal condition causing malabsorption or obstruction (e.g. celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
- •-Has been on any hormonal treatment (including progestin-containing IUD) for CAH/EIN or low grade (grade 1 or grade 2) endometrial carcinoma in last 3 months.
- •-Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e. black cohosh) or has been on progestin (including progestin containing IUD), tamoxifen or aromatase inhibitor within the prior 3 months.
- •-Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s wort as these may significantly reduce the availability of exemestane.
- •-Known hypersensitivity to exemestane or its excipients.
- •-Known intercurrent illness or psychiatric illness/social situations that will limit compliance with study requirements.
- •-Evidence or high suspicion of metastatic disease at enrollment.
- •-Women with severe bone density issues/osteoporosis (defined as any medical treatment for osteoporosis, and/or a T-score of -2.5 or lower, and/or history of fracture of the hip or spine).
- •-Unwilling or unable to undergo research biopsy during the baseline (pre-surgical) clinic visit, or inadequate research biopsy obtained during the baseline (pre-surgical) clinic visit (determined by the gynecologic oncologist at the time of the subject’s pelvic exam).
研究者
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