CompletedPhase 2

Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer

United States77 participantsStarted 2012-08-14

Plain-language 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.

Who can participate

Age range18 Years

SexMALE

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Exclusion criteria

✕. a modified activated protein C reaction ratio ≤ 2.5 and a Factor V Leiden gene mutation,
✕. an antithrombin level below the lower limit of the normal range,
✕. an antiphospholipid antibody level that is indeterminate, positive, or outside the normal range,
✕. or a prothrombin gene mutation

What they're measuring

Decline in Serum PSA

Timeframe: 120 days

Trial details

NCT IDNCT01615120

SponsorGTx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-09

Results submitted2021-01-28

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