IRB #

STUDY00016390

Title

A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Seviteronel plus Dexamethasone (SEVI-D) in Subjects with Advanced Breast Cancer

Principal Investigator

Jacqueline Vuky

Study Purpose

The purpose of this research study is to test the safety of a drug called Seviteronel. Seviteronel is an oral drug that may block the growth of cancer cells in multiple types of breast cancer.

Medical Condition(s)

Group 1: Female patients with AR+ triple negative breast cancer “Triple negative” means that your breast cancer is negative for estrogen, progesterone, and Human Epidermal growth factor (HER2) Receptors. AR+ means that your cancer has tested positive for the androgen receptor
Group 2: Female ER (+) breast cancer patients. ER+ means that your breast cancer is positive for estrogen receptors- CLOSED
Group 3: Male patients with breast cancer

Eligibility Criteria

1. Male or female age 18 or older
2. Confirmed invasive breast cancer

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

This study will take place over about 24 months. Study treatment will continue until your disease progresses, you can’t tolerate the treatment, or you and/or your doctor decide to stop treatment. After that participants will be contacted by phone every 12 weeks until the end of the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
knight@ohsu.edu

Sponsor

Innocrin Pharmaceuticals, Inc.

Recruitment End

12/15/2030

Compensation Provided

No


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