ER+ and AR+ Breast CancerPhase 2NCT02746328
Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass
A Phase 2 study testing GTx-024 9 or 18 mg in people with ER+ and AR+ Breast Cancer, run by GTx at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- ER+ and AR+ Breast Cancer
- What is being tested?
- GTx-024 9 or 18 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Feb 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In screening for, and ultimately randomized into, protocol G200802
- Give voluntary, written and signed, informed consent for this add-on study
- Age 18 to 70 years old
- Physically capable of mounting and riding a stationary bicycle
- Subject agrees to not significantly alter physical activity or current physical training during the study period
Who cannot join
- Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator
- Subjects unwilling to or unable to comply with the protocol
- Any other condition which per investigators' judgement may increase subject risk
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, School of Medicine
Seattle, Washington, 98109
About this study
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.
- Conditions
- ER+ and AR+ Breast Cancer
- Being tested
- GTx-024 9 or 18 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTx-024 9 or 18 mgDrug
Also called Enobosarm
Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
| Study group | Role | What they receive |
|---|---|---|
| GTx-024 9 or 18 mg | Experimental | Patients enrolled in G200802 receiving GTx-024 9 or 18 mg Receives: Drug: GTx-024 9 or 18 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 Weeks
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 Weeks
Optimal Pedaling Rate
Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Why it stopped: Investigational drug development was halted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER+ and AR+ Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hannah M Linden, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746328
- Sponsor's protocol ID
- G200802a
- Status last verified
- Feb 2024
- First submitted
- 18 Apr 2016
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass
- ClinicalTrials.gov ID
- NCT02746328
- Acronym / sponsor ID
- G200802a
- Conditions
- ER+ and AR+ Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigational drug development was halted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GTx-024 9 or 18 mg | Experimental | Drug: GTx-024 9 or 18 mgPatients enrolled in G200802 receiving GTx-024 9 or 18 mg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In screening for, and ultimately randomized into, protocol G200802
- Give voluntary, written and signed, informed consent for this add-on study
- Age 18 to 70 years old
- Physically capable of mounting and riding a stationary bicycle
- Subject agrees to not significantly alter physical activity or current physical training during the study period
Key exclusion criteria (3 listed)
- Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator
- Subjects unwilling to or unable to comply with the protocol
- Any other condition which per investigators' judgement may increase subject risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTx-024 9 or 18 mgAlso: EnobosarmPatients enrolled in G200802 receiving GTx-024 9 or 18 mg | Drug | GTx-024 9 or 18 mg |
Primary outcome
Maximal Power Production
Time frame: 24 Weeks
Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry
6 secondary outcomes
Maximal Power Production
Time frame: 12 Weeks
Lean Body Mass
Time frame: 24 Weeks
Lean Body Mass
Time frame: 12 Weeks
Maximal Power Production, Scaled to Total Body Mass
Time frame: 24 Weeks
Maximal Power Production, Scaled to Lean Body Mass
Time frame: 24 Weeks
Optimal Pedaling Rate
Time frame: 24 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah M Linden, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GTx-024 9 or 18 mg in people with ER+ and AR+ Breast Cancer, run by GTx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Power Production (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.