Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass

February 22, 2024 updated by: GTx
This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. In screening for, and ultimately randomized into, protocol G200802
  2. Give voluntary, written and signed, informed consent for this add-on study
  3. Age 18 to 70 years old
  4. Physically capable of mounting and riding a stationary bicycle
  5. Subject agrees to not significantly alter physical activity or current physical training during the study period

Exclusion Criteria:

  1. Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator
  2. Subjects unwilling to or unable to comply with the protocol
  3. Any other condition which per investigators' judgement may increase subject risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GTx-024 9 or 18 mg
Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
Drug: GTx-024 9 or 18 mg
Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
Other Names:
  • Enobosarm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Power Production
Time Frame: 24 Weeks
Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry
24 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal Power Production
Time Frame: 12 Weeks
Describe the effect of 12 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry
12 Weeks
Lean Body Mass
Time Frame: 24 Weeks
Describe the effect of 24 weeks of treatment of GTx-024 on lean body mass (LBM) as assessed by CT images of the lumbar region from L3 to the iliac crest
24 Weeks
Lean Body Mass
Time Frame: 12 Weeks
Describe the effect of 12 weeks of treatment of GTx-024 on LBM as assessed by CT images of the lumbar region from L3 to the iliac crest
12 Weeks
Maximal Power Production, Scaled to Total Body Mass
Time Frame: 24 Weeks
Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to total body mass (TBM), as assessed by inertial-load cycle ergometry
24 Weeks
Maximal Power Production, Scaled to Lean Body Mass
Time Frame: 24 Weeks
Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to LBM, as assessed by inertial-load cycle ergometry
24 Weeks
Optimal Pedaling Rate
Time Frame: 24 Weeks
Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate
24 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory Objective
Time Frame: 24 Weeks
Describe the impact of baseline measures and measures obtained throughout the study on maximal power production and its change from baseline
24 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GTx

Investigators

  • Principal Investigator: Hannah M Linden, MD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

April 18, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimated)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • G200802a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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