NCT02718144CompletedPhase 1
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 sites in 1 country12 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- The number of patients with a dose limiting toxicity (DLT)
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
estetrol
Experimental
3 + 3 design with inter-patient dose escalation
Intervention: Estetrol (Drug)
Outcomes
Primary Outcomes
The number of patients with a dose limiting toxicity (DLT)
Time Frame: 4 weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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