NCT02718144已完成1 期
A Phase I/II Clinical Trial Assessing Safety and Efficacy of Estetrol (E4) in Postmenopausal Women With Advanced Estrogen Receptor Positive (ER+) Breast Cancer
Pantarhei Oncology B.V.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The number of patients with a dose limiting toxicity (DLT)
研究概览
简要总结
This is a multi-center, open-label, phase I/IIa trial, dose-escalation study with a 3 + 3 cohort design to determine the recommended dose of estetrol for the treatment of patients with advanced breast cancer. After completing phase I part of the study (i.e. 4 weeks of treatment), patients will receive further treatment for 8 weeks at their individual phase I dose level (phase IIa part of the study).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women with ER-positive and HER2-negative locally advanced and/or metastatic breast cancer, who progressed on standard therapies or for whom standard therapies are intolerant;
- •Patients should have experienced a natural or surgical menopause at least 5 years ago;
- •Failure of anti-estrogen treatment with tamoxifen and aromatase inhibitor(s) due to the development of resistance or unacceptable side effects with this treatment;
- •No undiagnosed vaginal bleeding;
- •No treatment with fulvestrant within 6 months of start of treatment;
- •Life expectancy at least 6 months;
- •Tumour assessment (CT scan) before the start of the E4 treatment;
- •Body mass index (BMI) between (≥) 18 and (≤) 35 kg/m2;
- •Able to swallow an oral medication;
- •Acceptable values of hematological parameters, liver and kidney function and calcium levels;
- •Acceptable values of hemostasis parameters (as of second cohort);
- •Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2 (as of second cohort);
- •Reasonable physical and mental health as judged by the investigator and determined by physical examination, clinical laboratory assessments and vital signs;
- •Willing to give informed consent in writing.
排除标准
- •Uncontrolled nausea, vomiting, or diarrhea;
- •History of venous or arterial thromboembolic disease or a known defect in the blood coagulation system;
- •History of severe cardiac events or life threatening cardiac dysrhythmia (as of second cohort);
- •Patients who have unstable angina or clinical congestive heart failure (as of second cohort);
- •Uncontrolled hypertension, i.e. systolic blood pressure 160 mmHg and/or diastolic blood pressure 100 mmHg in the last 6 months with or without medication;
- •Diabetes mellitus with poor glycaemic control in the last 6 months (HbA1c above 7.5%);
- •Any other serious disease including systemic lupus erythematosus and untreated cholelithiasis;
- •Smoking >10 cigarettes/day;
- •Use of any other cancer therapy including radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, chemotherapy, or use of other investigational agents at the start of treatment.
研究组 & 干预措施
estetrol
Experimental
3 + 3 design with inter-patient dose escalation
干预措施: Estetrol (Drug)
结局指标
主要结局
The number of patients with a dose limiting toxicity (DLT)
时间窗: 4 weeks
次要结局
- Preliminary anti-tumour response according to RECIST 1.1(12 weeks)
- Pharmacokinetics: estetrol trough levels(2 weeks, 4 weeks, 8 weeks)
- Questionnaire on estrogen deficiency symptoms(12 weeks)
研究者
研究点 (2)
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