Safety Study of Enzalutamide (MDV3100) in Patients With Incurable Breast Cancer
Information source: Medivation, Inc.
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: enzalutamide (Drug); anastrozole (Drug); exemestane (Drug); fulvestrant (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Medivation, Inc.
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.
Clinical Details
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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the safety and tolerability of daily enzalutamideTo evaluate the safety and tolerability of daily enzalutamide plus anastrozole To evaluate the safety and tolerability of daily enzalutamide plus exemestane 25 mg/day To evaluate the safety and tolerability of daily enzalutamide plus exemestane 50 mg/day To evaluate the safety and tolerability of daily enzalutamide plus fulvestrant
Secondary outcome: To characterize the pharmacokinetic properties of enzalutamideTo characterize the pharmacokinetic properties of enzalutamide plus anastrozole To characterize the pharmacokinetic properties of enzalutamide plus exemestane
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Aurora, Colorado 80045, United States
Sarasota, Florida 34232, United States
Detroit, Michigan 48201, United States
New York, New York 10065, United States
Memphis, Tennessee 38120, United States
Nashville, Tennessee 37203, United States
Additional Information
Starting date: April 2012
Last updated: August 11, 2015
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