NCT02746328

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

April 18, 2016

Last Update Submit

February 22, 2024

Conditions

ER+ and AR+ Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Maximal Power Production

    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 Outcomes (6)

  • Maximal Power Production

    12 Weeks

  • Lean Body Mass

    24 Weeks

  • Lean Body Mass

    12 Weeks

  • Maximal Power Production, Scaled to Total Body Mass

    24 Weeks

  • Maximal Power Production, Scaled to Lean Body Mass

    24 Weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • Exploratory Objective

    24 Weeks

Study Arms (1)

GTx-024 9 or 18 mg

EXPERIMENTAL

Patients enrolled in G200802 receiving GTx-024 9 or 18 mg

Drug: GTx-024 9 or 18 mg

Interventions

GTx-024 9 or 18 mgDRUG

Patients enrolled in G200802 receiving GTx-024 9 or 18 mg

Also known as: Enobosarm
GTx-024 9 or 18 mg

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington, School of Medicine

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

ostarine

Study Officials

  • Hannah M Linden, MD

    University of Washington

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

US(1)