CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 77 enrolled
Drug / intervention
GTx-758 125 mg +1 moredrug
Likely dose
GTx-758 125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01615120
NCT01615120Phase 2Completed
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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

GTx·interventional·Posted Jun 8, 2012·Updated Mar 24, 2021

In Brief

A Phase 2 clinical trial evaluating GTx-758 125 mg and GTx-758 250 mg for Prostate Cancer. Completed, enrolled 77 participants across 26 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 8, 2012
Enrollment StartAug 14, 2012
Primary CompletionNov 9, 2016
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 14.1 years ago

Interventions

GTx-758 125 mgdrug

One 125 mg tablet once a day

GTx-758 250 mgdrug

two 125 mg tablets once daily