IRB #

STUDY00015561

Title

A Phase Ib/II, Multicentre, Open Label, Randomised Study of BI 836845 in Combination with Enzalutamide, versus Enzalutamide alone, in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Following Disease Progression on Docetaxel-Based Chemotherapy and Abiraterone. Protocol 1280.8

Principal Investigator

Tomasz Beer

Study Purpose

The purpose of this study is to test the safety, tolerability and effects of the study drug, called BI 836845, when used with along with enzalutamide. Enzalutamide is already approved by the US Food and Drug Administration (FDA) for use in prostate cancer. The use of the study drug is experimental. It has not been approved by the FDA.

Medical Condition(s)

Prostate Cancer
Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

- Metastatic prostate cancer that no longer responds to standard androgen deprivation therapy
- Currently receiving enzalutamide, but cancer returning in spite of enzalutamide therapy
- have a metastatic lesion that is able to be biopsied

Age Range

18 - NA

Healthy Volunteers Needed

No

Duration of Participation

Approximately 10-12 months

Minors Included

No

Contact

Clinical Trials Information Line: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Boehringer Ingelheim Pharmaceuticals, Inc.

Recruitment End

01/04/2021

Compensation Provided

No


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