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

NCT ID: NCT02746328

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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ER+ and AR+ Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GTx-024 9 or 18 mg

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

Group Type EXPERIMENTAL

GTx-024 9 or 18 mg

Intervention Type DRUG

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

Interventions

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GTx-024 9 or 18 mg

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

Intervention Type DRUG

Other Intervention Names

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Enobosarm

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GTx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah M Linden, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

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University of Washington, School of Medicine

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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G200802a

Identifier Type: -

Identifier Source: org_study_id

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