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

GTx

Status and phase: Withdrawn; Phase 2

Conditions: ER+ and AR+ Breast Cancer

Treatments: Drug: GTx-024 9 or 18 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02746328

G200802a

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

GTx-024 9 or 18 mg

Experimental group

Description:

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

Treatment:

Drug: GTx-024 9 or 18 mg