Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments enzalutamide, anastrozole, exemestane, fulvestrant
Phase phase 1
Target androgen receptor
Sponsor Medivation, Inc.
Collaborator Astellas Pharma Inc
Start date April 2012
End date December 2015
Trial size 101 participants
Trial identifier NCT01597193, MDV3100-08

Summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of enzalutamide alone and in combination with anastrozole, or exemestane, or fulvestrant in patients with incurable breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
enzalutamide be provided as two or four 40-mg capsules by mouth daily
enzalutamide MDV3100, Xtandi
80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
(Experimental)
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with anastrozole (1 mg) administered as one 1-mg tablet by mouth once daily.
anastrozole Arimidex
1 mg/day
enzalutamide MDV3100
160 mg (4 capsules) taken orally daily.
(Experimental)
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as one 25-mg tablet daily
exemestane Aromasin
The exemestane dose is 25mg daily.
enzalutamide MDV3100
160 mg (4 capsules) taken orally daily.
(Experimental)
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with exemestane administered as two 25-mg tablets daily
enzalutamide MDV3100
160 mg (4 capsules) taken orally daily.
exemestane Aromasin
The exemestane dose is 50 mg daily.
(Experimental)
enzalutamide (160 mg) administered as four 40-mg capsules by mouth once daily in combination with fulvestrant (500 mg) administered as two 250-mg intramuscular injections every 28 days
fulvestrant Faslodex
500 mg every 28 days
enzalutamide MDV3100
160 mg (4 capsules) taken orally daily.

Primary Outcomes

Measure
To evaluate the safety and tolerability of daily enzalutamide
time frame: 18 months
To evaluate the safety and tolerability of daily enzalutamide plus anastrozole
time frame: 18 months
To evaluate the safety and tolerability of daily enzalutamide plus exemestane 25 mg/day
time frame: 18 months
To evaluate the safety and tolerability of daily enzalutamide plus exemestane 50 mg/day
time frame: 18 months
To evaluate the safety and tolerability of daily enzalutamide plus fulvestrant
time frame: 18 months

Secondary Outcomes

Measure
To characterize the pharmacokinetic properties of enzalutamide
time frame: 5 months
To characterize the pharmacokinetic properties of enzalutamide plus anastrozole
time frame: 5 months
To characterize the pharmacokinetic properties of enzalutamide plus exemestane
time frame: 5 months
To characterize the pharmacokinetic properties of enzalutamide plus fulvestrant
time frame: 5 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed breast cancer with accompanying pathology report; - Submit unstained representative tumor specimen, either as a paraffin block (preferred) or ≥ 10 unstained slides - Received at least 2 lines of systemic therapy in the advanced setting (for enzalutamide alone arm only); - Eastern Cooperative Oncology Group performance (ECOG) status of 0 or 1; - Estimated life expectancy of at least 3 months Exclusion Criteria: - Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment; - Pregnant or lactating; - Known or suspected brain metastasis or leptomeningeal disease; - History of another malignancy within the previous 5 years other than curatively treated in situ carcinomas; - For patients who are enrolled to receive enzalutamide plus anastrozole or exemestane or fulvestrant must not have received tamoxifen or any medication known to be a potent CYP3A4 inducer or inhibitor.

Additional Information

Official title A Phase 1 Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Enzalutamide (Formerly MDV3100) in Patients With Incurable Breast Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Medivation, Inc..