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Clinical Trials/NCT02718144
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

Sponsor
Pantarhei Oncology B.V.
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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