Metastatic Breast CancerPhase 2NCT01616758
Phase II Study of GTx024 in Women With Metastatic Breast Cancer
A Phase 2 study testing GTx-024 9mg in people with Metastatic Breast Cancer, run by GTx at 4 sites in United States.
Trial summary
The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on physical function… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- GTx-024 9mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2013to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Give voluntary, signed informed consent in accordance with institutional policies.
- Be a woman that has been diagnosed with ER positive metastatic breast cancer.
- Have metastatic breast cancer with measurable lesions prior to enrollment or bone only disease prior to enrollment. A measurable lesion is defined as one lesion whose longest diameter (LD) can be accurately measured as 10 mm CT or MRI technique by using a 5 mm contiguous reconstruction algorithm. Measurable lesions must be at least 2 times the slice thickness or at least two times the size of the CT scan interval cut. Patients with bone only disease and non-measurable lesions are eligible.
- Be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medical or surgical menopause prior to the start of this study.(Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for > or equal to 6 months but < 12 months, they must have a serum FSH concentration of > or equal to 50 mIU/mL and an estradiol concentration of less than or equal to 25 pg/mL. Medical menopause is defined as treatment with a luteinizing hormone receptor hormone agonist and surgical menopause is defined as bilateral oophorectomy).
- Have been treated and responded to previous adjuvant hormonal therapy for 3 years or previous hormonal therapy for metastatic disease for 6 months prior to disease progression.
- Have not had radiation therapy for breast cancer within 2 weeks of randomization in this study and are not planned to have radiation therapy during participation in this study.
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- Be willing to provide a formalin-fixed, paraffin-embedded block(s) of cancerous tissue from a biopsy of a metastatic tumor lesion(s) collected during the two (2) years prior to study entry or as a component of enrollment in the study for determination of AR and ER status. Tissue samples from a biopsy of a primary tumor lesion will also be provided if available.
- Serum creatinine 2.0 mg/dL
- Have ECOG score 2.
- Be age 18 years.
Who cannot join
- Have triple negative breast cancer
- Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
- Have uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg and/or diastolic blood pressure greater than 100 mm Hg despite treatment with antihypertensive drugs)
- Untreated congestive heart failure or untreated angina
- Have Stage 4 chronic obstructive pulmonary disease (COPD)
- Have positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), unless subject was diagnosed > 10 years prior to enrollment and no evidence of active liver disease
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- The presence of consistently abnormal clinical laboratory test (Appendix B) values which are considered clinically significant. In addition, any subject with total bilirubin above 2 times the upper limit of normal (ULN) or liver enzymes ( ALT/SGOT or AST/SGPT) above 1.5 times the ULN without evidence of liver metastases or above 5 times the ULN in subjects with evidence of liver metastases will not be admitted to the study
- Have positive screen for hepatitis A antibody IgM or HIV
- Have received chemotherapy for metastatic breast cancer within the 3 months prior to enrollment in the study or be expected to receive chemotherapy for metastatic breast cancer during the study
- Be currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin®),oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone (DHEA), androstenedione, and other androgenic compounds, including herbals), or antiandrogens. Previous therapy with testosterone and testosterone-like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the medical monitor (1-877-693-2723) for this study to determine appropriate washout period).
- Have untreated or uncontrolled brain metastasis
- Have been diagnosed with or treated for cancer within the previous two years, other than breast cancer or non-melanoma carcinoma of the skin.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02110
Commonwealth Hematology-Oncology
Lawrence, Massachusetts, 01841
AMPM Research Clinic
Miami, Florida, 33145
Illinois Cancer Care, PC
Peoria, Illinois, 61615
About this study
Official title: Phase II, Open Label Study to Examine Androgen Receptor Status and the Activity of GTx-024 Hormonal Therapy in Women With Estrogen Receptor Positive Metastatic Breast Cancer Who Have Previously Responded to Hormone Therapy
The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on physical function, and effects on tumor progression in women with Androgen Receptor positive breast cancer will also be assessed.
Read the detailed description
This is an open label, multicenter study to assess the safety and efficacy of GTx-024 in female subjects who have estrogen receptor (ER) positive metastatic breast cancer and who have responded previously to hormone therapy. Subjects may have received up to 3 prior hormonal therapies for the treatment of breast cancer. Subjects must have responded to adjuvant hormonal therapy for > 3 years or hormonal therapy for metastatic disease for > 6 months before progression to be eligible for this study.
The primary efficacy analysis will be the clinical benefit in subjects with AR positive breast cancer at 6 months as measured by a modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) classification. Key secondary endpoints of clinical benefit in all subjects and AR negative subjects, as well as objective response rate, progression free survival, time to progression, duration of response, incidence of SREs, and time to first SRE in subsets based on AR status will also be assessed.
- Conditions
- Metastatic Breast Cancer
- Being tested
- GTx-024 9mg
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTx-024 9mgDrug
Also called GTx-024 dosage of three soft gels once daily to equal 9mg
| Study group | Role | What they receive |
|---|---|---|
| GTx-024 9mg | Experimental | GTx-024 dosage of three soft gels once daily to equal 9mg Receives: Drug: GTx-024 9mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Treated With GTx024 With Clinical Benefit With AR Positive Breast Cancer
N=17 of 22 subjects with AR Positive Breast Cancer - Clinical Benefit is defined as a complete response (CR), partial response (PR), or stable disease (SD).
Measured: 6 months
Secondary outcomes (2)
Percentage of Subjects Treated With GTx024 With Clinical Benefit (All Subjects)
Clinical Benefit is defined as a complete response (CR), partial response (PR), or stable disease (SD).
Measured: 6 Months
Percentage of Subjects Treated With GTx024 Achieving Objective Response by 1 Year of Treatment
Objective Response is defined as achieving Complete or Partial Response on Tumor Assessments
Note: Due to zero subject achieving response, all subsequent outcome measures related to response cannot be conducted.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2012 (estimated)
- Study startApr 2013
- Primary completionJun 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- GTx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mayzie Johnston, PharmD, Study director, GTx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616758
- Sponsor's protocol ID
- G200801
- Status last verified
- Mar 2024
- First submitted
- 7 Jun 2012
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Open Label Study to Examine Androgen Receptor Status and the Activity of GTx-024 Hormonal Therapy in Women With Estrogen Receptor Positive Metastatic Breast Cancer Who Have Previously Responded to Hormone Therapy
- ClinicalTrials.gov ID
- NCT01616758
- Acronym / sponsor ID
- G200801
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 22 participants (actual)
- Lead sponsor
- GTxIndustry (pharma, biotech, devices)
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jun 2012 (estimated)
- Results
- Posted 8 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary efficacy analysis will be the clinical benefit at 6 months as measured by a modified Response Evaluation Criteria in Solid Tumors RECIST classification. Key secondary endpoints of objective response rate, progression free survival, time to progression, duration of response, effects on physical function, and effects on tumor progression in women with Androgen Receptor positive breast cancer will also be assessed.
Detailed description
This is an open label, multicenter study to assess the safety and efficacy of GTx-024 in female subjects who have estrogen receptor (ER) positive metastatic breast cancer and who have responded previously to hormone therapy. Subjects may have received up to 3 prior hormonal therapies for the treatment of breast cancer. Subjects must have responded to adjuvant hormonal therapy for > 3 years or hormonal therapy for metastatic disease for > 6 months before progression to be eligible for this study.
The primary efficacy analysis will be the clinical benefit in subjects with AR positive breast cancer at 6 months as measured by a modified Response Evaluation Criteria In Solid Tumors (RECIST 1.1) classification. Key secondary endpoints of clinical benefit in all subjects and AR negative subjects, as well as objective response rate, progression free survival, time to progression, duration of response, incidence of SREs, and time to first SRE in subsets based on AR status will also be assessed.
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 9mg | Experimental | Drug: GTx-024 9mgGTx-024 dosage of three soft gels once daily to equal 9mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Give voluntary, signed informed consent in accordance with institutional policies.
- Be a woman that has been diagnosed with ER positive metastatic breast cancer.
- Have metastatic breast cancer with measurable lesions prior to enrollment or bone only disease prior to enrollment. A measurable lesion is defined as one lesion whose longest diameter (LD) can be accurately measured as 10 mm CT or MRI technique by using a 5 mm contiguous reconstruction algorithm. Measurable lesions must be at least 2 times the slice thickness or at least two times the size of the CT scan interval cut. Patients with bone only disease and non-measurable lesions are eligible.
- Be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medical or surgical menopause prior to the start of this study.(Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for > or equal to 6 months but < 12 months, they must have a serum FSH concentration of > or equal to 50 mIU/mL and an estradiol concentration of less than or equal to 25 pg/mL. Medical menopause is defined as treatment with a luteinizing hormone receptor hormone agonist and surgical menopause is defined as bilateral oophorectomy).
- Have been treated and responded to previous adjuvant hormonal therapy for 3 years or previous hormonal therapy for metastatic disease for 6 months prior to disease progression.
Key exclusion criteria (12 listed)
- Have triple negative breast cancer
- Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
- Have uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg and/or diastolic blood pressure greater than 100 mm Hg despite treatment with antihypertensive drugs)
- Untreated congestive heart failure or untreated angina
- Have Stage 4 chronic obstructive pulmonary disease (COPD)
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 9mgAlso: GTx-024 dosage of three soft gels once daily to equal 9mg | Drug | GTx-024 9mg |
Primary outcome
Percentage of Subjects Treated With GTx024 With Clinical Benefit With AR Positive Breast Cancer
Time frame: 6 months
N=17 of 22 subjects with AR Positive Breast Cancer - Clinical Benefit is defined as a complete response (CR), partial response (PR), or stable disease (SD).
2 secondary outcomes
Percentage of Subjects Treated With GTx024 With Clinical Benefit (All Subjects)
Time frame: 6 Months
Percentage of Subjects Treated With GTx024 Achieving Objective Response by 1 Year of Treatment
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mayzie Johnston, PharmD study director
GTx
4 sites 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 9mg in people with Metastatic Breast Cancer, run by GTx at 4 sites 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 10 inclusion and 12 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: stopped early, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 8 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Treated With GTx024 With Clinical Benefit With AR Positive Breast Cancer (time frame: 6 months). 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 8 Mar 2024.