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

ER+ and AR+ Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02746328
• Other study ID #: G200802a
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: February 2024
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• ER+ and AR+ Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington, School of Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Objective	Describe the impact of baseline measures and measures obtained throughout the study on maximal power production and its change from baseline	24 Weeks
Primary	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	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	12 Weeks
Secondary	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	24 Weeks
Secondary	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	12 Weeks
Secondary	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	24 Weeks
Secondary	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	24 Weeks
Secondary	Optimal Pedaling Rate	Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate	24 Weeks