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

Phase 2

Withdrawn

• Conditions: ER+ and AR+ Breast Cancer
• Interventions: Drug: GTx-024 9 or 18 mg

• Registration Number: NCT02746328
• Lead Sponsor: GTx

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-18
• Study First Submitted QC: 2016-04-18
• Study First Posted: 2016-04-21
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximal Power Production	24 Weeks	Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry

Secondary Outcome Measures

Name	Time	Method
Maximal Power Production, Scaled to Total Body Mass	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
Maximal Power Production, Scaled to Lean Body Mass	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
Lean Body Mass	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
Optimal Pedaling Rate	24 Weeks	Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate
Maximal Power Production	12 Weeks	Describe the effect of 12 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry

Trial Locations

Locations (1)

University of Washington, School of Medicine; 🇺🇸 Seattle, Washington, United States