GTx: Clinical Trials

11 completed, 5 terminated, 4 withdrawn. 14 Phase 2, 5 Phase 3, 1 Phase 1.

By phase and status

Phase	Trials	Status
Phase 2	14	Completed 6, Terminated 5, Withdrawn 3
Phase 3	5	Completed 4, Withdrawn 1
Phase 1	1	Completed 1

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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

Trial	Phase	Status	Sponsor	Enrollment	Start	Updated
Study to Assess Long-Term Safety/Tolerability of Enobosarm (GTx 024) in Stress Urinary Incontinence GTx-024 - Stress Urinary Incontinence	Phase 2	Withdrawn	GTx		2018-06-28	2024-03-01
Durability Extension Study to Assess Clinical Activity and Safety of Enobosarm (GTx-024) in Stress Urinary Incontinence GTx-024, Matching Placebo - Stress Urinary Incontinence	Phase 2	Withdrawn	GTx		2018-05-28	2023-09-14
Study to Assess Enobosarm (GTx-024) in Postmenopausal Women With Stress Urinary Incontinence GTx 024, Placebo - Stress Urinary Incontinence	Phase 2	Completed	GTx	491	2017-08-21	2021-03-24
Enobosarm and Anastrozole in Pre-menopausal Women With High Mammographic Breast Density enobosarm - Mammographic Density	Phase 1	Completed	Havah Therapeutics Pty Ltd	9	2017-02-01	2018-04-18
Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass GTx-024 9 or 18 mg - ER+ and AR+ Breast Cancer	Phase 2	Withdrawn	GTx		2016-04-01	2024-02-26
GTx-024 as a Treatment for Stress Urinary Incontinence in Women GTx-024 - Stress Urinary Incontinence	Phase 2	Completed	GTx	19	2016-01-01	2021-02-01
Efficacy and Safety of GTx-024 in Patients With Estrogen Receptor (ER)+/Androgen Receptor (AR)+ Breast Cancer GTx-024 - ER+ and AR+ Breast Cancer	Phase 2	Completed	GTx	136	2015-08-01	2020-12-09
Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC) GTx-024 - Triple Negative Breast Cancer	Phase 2	Terminated	GTx	32	2015-06-01	2020-11-18
Phase II Study of GTx024 in Women With Metastatic Breast Cancer GTx-024 9mg - Metastatic Breast Cancer	Phase 2	Terminated	GTx	22	2013-04-01	2024-03-08
Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer GTx-758 125 mg, GTx-758 250 mg - Prostate Cancer	Phase 2	Completed	GTx	77	2012-08-14	2021-03-24
GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer GTx-758 - Prostate Cancer	Phase 2	Terminated	GTx	18	2011-09-01	2023-10-06
Phase II, Dose Finding Study of GTx-758 GTx-758 - Prostate Cancer	Phase 2	Terminated	GTx	77	2011-08-01	2024-04-22
Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum GTx-024, placebo - Muscle Wasting, Non-Small Cell Lung Cancer	Phase 3	Completed	GTx	330	2011-07-01	2020-11-09
Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) GTx-024, placebo - Muscle Wasting, Non Small Cell Lung Cancer	Phase 3	Completed	GTx	321	2011-07-01	2016-03-03
Effect of GTx-758 on Total and Free Testosterone Levels in Men With Prostate Cancer GTx-758 1000mg, Lupron Depot, GTx-758 2000mg - Prostate Cancer	Phase 2	Terminated	GTx	159	2011-06-01	2023-06-22
Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer Toremifene - Risk of Bone Fracture Occurrences	Phase 3	Withdrawn	GTx		2011-03-01	2013-11-15
Study of GTx-024 on Muscle Wasting (Cachexia) Cancer. GTx-024, Placebo - Cachexia	Phase 2	Completed	GTx	159	2007-05-01	2014-07-11
Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia) Toremifene 20 mg, Placebo - Preneoplastic Conditions, Prostatic Intraepithelial Neoplasia	Phase 3	Completed	GTx	1589	2005-01-01	2023-06-12
Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy Toremifene Citrate - Prostate Cancer, Osteoporosis	Phase 3	Completed	GTx	1200	2003-10-01	2013-11-15
A Chemoprevention Study of an Investigational Drug in Men With High Grade Prostate Intraepithelial Neoplasia (PIN) GTX-006 (Acapodene) - Prostatic Intraepithelial Neoplasia	Phase 2	Completed	GTx	500	2001-04-01	2013-11-15

Conditions studied

Prostatic Neoplasms (6)  ·  Urinary Incontinence, Stress (4)  ·  Carcinoma, Non-Small-Cell Lung (3)  ·  Muscular Atrophy (3)  ·  Fractures, Bone (2)  ·  Prostatic Intraepithelial Neoplasia (2)  ·  Bone Diseases, Metabolic (1)  ·  Breast Neoplasms (1)  ·  Cachexia (1)  ·  Colorectal Neoplasms (1)  ·  Lymphoma, Non-Hodgkin (1)  ·  Neoplasms (1)  ·  Osteoporosis (1)  ·  Precancerous Conditions (1)  ·  Triple Negative Breast Neoplasms (1)

Interventions

ostarine (12)  ·  3-fluoro-N-(4-fluorophenyl)-4-hydroxy-N-(4-hydroxyphenyl)benzamide (4)  ·  Toremifene (4)  ·  Anastrozole (1)  ·  Leuprolide (1)

Countries

United States (19)  ·  Canada (2)  ·  Argentina (1)  ·  Australia (1)  ·  Mexico (1)

Top investigators

Mitchell Steiner, MD (4)  ·  Kenneth Peters, MD (2)  ·  Beth A Overmoyer, MD (1)  ·  Hannah M Linden, MD (1)  ·  Hope S Rugo, MD (1)  ·  Kenneth M Peters, MD (1)  ·  Kenneth M. Peters, MD (1)  ·  Mayzie Johnston, PharmD (1)  ·  Mitchell Steiner, M.D. (1)  ·  Samir Taneja, MD (1)  ·  Stephen N Birrell, MD PhD (1)

Results publications

PMID 27138015, PMID 22245322, PMID 23234631, PMID 23295793, PMID 23499390, PMID 24968970, PMID 38342115