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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 enzalutamide

To 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 enzalutamide

To 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

Page last updated: August 20, 2015

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