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临床试验/NCT02718144
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

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

发起方
Pantarhei Oncology B.V.
申办方类型
Other
责任方
Sponsor

研究点 (2)

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