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

GTx

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

ER+ and AR+ Breast Cancer

Interventions

GTx-024 9 or 18 mgDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Washington, School of Medicine

Seattle, Washington, United States

Outcomes

Primary Outcomes

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

Time frame: 24 Weeks

Secondary Outcomes

Maximal Power Production

Describe the effect of 12 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry

Time frame: 12 Weeks

Lean Body Mass

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

Time frame: 24 Weeks

Lean Body Mass

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

Time frame: 12 Weeks

Maximal Power Production, Scaled to Total Body Mass

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

Time frame: 24 Weeks

Maximal Power Production, Scaled to Lean Body Mass

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

Time frame: 24 Weeks

Optimal Pedaling Rate

Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate

Time frame: 24 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.