CLINICAL TRIALS PROFILE FOR ENOBOSARM

Clinical Trials for Enobosarm

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT01355497 ↗	Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum	Completed	GTx	Phase 3	The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.
NCT02368691 ↗	Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)	Terminated	GTx	Phase 2	The purpose of this study is to determine if GTx-024 is effective and safe in the treatment of patients with advanced, androgen receptor positive triple negative breast cancer (AR+ TNBC).
NCT02658448 ↗	GTx-024 as a Treatment for Stress Urinary Incontinence in Women	Completed	GTx	Phase 2	The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.
NCT02746328 ↗	Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass	Completed	Martin Performance	Phase 2	This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.
NCT02746328 ↗	Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass	Completed	GTx	Phase 2	This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.
NCT02971761 ↗	Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than pembrolizumab alone in treating patients with androgen receptor positive triple negative breast cancer.
NCT02971761 ↗	Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer	Active, not recruiting	City of Hope Medical Center	Phase 2	This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than pembrolizumab alone in treating patients with androgen receptor positive triple negative breast cancer.

Clinical Trial Conditions for Enobosarm

Condition Name

Condition Name for
Intervention	Trials
Stress Urinary Incontinence	4
Metastatic Breast Cancer	2
Stage IV Breast Cancer	1
Stage IV Breast Cancer AJCC v6 and v7	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Urinary Incontinence, Stress	4
Urinary Incontinence	4
Enuresis	4
Breast Neoplasms	4

Clinical Trial Locations for Enobosarm

Trials by Country

Trials by Country for
Location	Trials
United States	128
Poland	1
Ukraine	1
Australia	1
Spain	1

Trials by US State

Trials by US State for
Location	Trials
Texas	6
Pennsylvania	6
Michigan	6
Massachusetts	6
Florida	6

Clinical Trial Progress for Enobosarm

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	2
Phase 2	8
Phase 1	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	5
Terminated	3
Active, not recruiting	1

Clinical Trial Sponsors for Enobosarm

Sponsor Name

Sponsor Name for
Sponsor	Trials
GTx	8
Veru Inc.	2
Havah Therapeutics Pty Ltd	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	11
Other	2
NIH	1