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NCT01615120 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostate Cancer, sponsored by GTx.

Completed
Registry status
Phase 2
Development phase
77
Enrollment target
20
Study locations

NCT01615120 is a Phase 2 study of Prostate Cancer that has completed, run by GTx. The registered enrollment target is 77 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT01615120, a Phase 2 study of Prostate Cancer, has completed, sponsored by GTx.

COMPLETED
Registry status
Phase 2
Development phase
77 participants
Enrollment target
20
Study locations

Study 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 Studied

Prostate Cancer

Interventions

  • DRUG GTx-758 125 mg
  • DRUG GTx-758 250 mg

Study Locations (20)

California

  • Urology Associates Medical Group - Burbank
  • VA of Greater Los Angeles - Los Angeles
  • Tower Urology - Los Angeles
  • San Bernardino Urological Assoc. - San Bernardino
  • Genesis Healthcare Partners - San Diego
  • Urology Specialists of So. California - Torrance

Florida

  • So. Florida Medical Research - Aventura
  • AMPM Research - Miami
  • Coastal Medical Center - Sarasota
  • GTx Investigative Site - St. Petersburg
  • Pinellas Urology - St. Petersburg

New York

  • Urological Institute of NE New York - Albany
  • AMP of NY - Oneida
  • AMP of NY - Syracuse

Indiana

  • Urology of Indiana - Greenwood
  • First Urology PSC - Jeffersonville

Colorado

  • Univ. of Colorado Cancer Center - Aurora

Connecticut

  • Connecticut Clinical Research Center - Middlebury

Maryland

  • Chesapeake Urology Research Assoc. - Towson

Montana

  • Five Valleys Urology - Missoula

Trial Details

FieldValue
Enrollment Target 77 participants
Start Date 2012-08-14
Est. Completion 2016-11-09
Phase Phase 2

Sponsor

GTx

15 total trials

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What the Registry Record Tells You About NCT01615120

The ClinicalTrials.gov registry entry for NCT01615120 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (87% lower). The listed sponsor is GTx, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which GTx-758 125 mg is the first listed.

NCT01615120 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT01615120 about?

NCT01615120 is a clinical study titled "Study of the Effect of GTx-758 on Serum PSA and Testosterone in Men With Prostate Cancer". 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 ...

What is the current status of trial NCT01615120?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2012-08-14. Estimated completion is 2016-11-09.

What conditions does trial NCT01615120 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT01615120?

The interventions under investigation include: GTx-758 125 mg (DRUG), GTx-758 250 mg (DRUG).

Who is sponsoring clinical trial NCT01615120?

This trial is sponsored by GTx, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01615120 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.