Trials / Completed
CompletedNCT01615120
Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer
Phase II, Open Label Study of the Effect of GTx-758 as Secondary Hormonal Therapy on Serum PSA and Serum Free Testosterone Levels in Men With Metastatic Castration Resistant Prostate Cancer Maintained on Androgen Deprivation Therapy
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- Sponsor
- GTx · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Protocol G200712 is a Phase II, exploratory study to assess the effects of GTx-758 on serum prostate specific antigen (PSA) response ans serum PSA progression in men with Metastatic Castration Resistant Prostate Cancer (mCRPC) on Androgen Deprivation Therapy (ADT) with luteinizing hormone-releasing hormone (LHRH) agonists, LHRH antagonists, or orchidectomy. This study will also assess the venous thromboembolism (VTE) risk of lower doses of GTx-758.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GTx-758 125 mg | One 125 mg tablet once a day |
| DRUG | GTx-758 250 mg | two 125 mg tablets once daily |
Timeline
- Start date
- 2012-08-14
- Primary completion
- 2016-11-09
- Completion
- 2016-11-09
- First posted
- 2012-06-08
- Last updated
- 2021-03-24
- Results posted
- 2021-02-16
Locations
26 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01615120. Inclusion in this directory is not an endorsement.