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

G

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Withdrawn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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems