Phase II Study of GTx024 in Women With Metastatic Breast Cancer

• ClinicalTrials.gov Identifier: NCT01616758
• Recruitment Status: Completed
• First Posted: June 12, 2012
• Last Update Posted: March 15, 2017
• Sponsor: GTx
• Information provided by (Responsible Party): GTx

Tracking Information

• First Submitted Date: June 7, 2012
• First Posted Date: June 12, 2012
• Last Update Posted Date: March 15, 2017
• Actual Study Start Date: April 2013
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 9, 2013): To assess Objective Response Rate in subjects treated with GTx024 [ Time Frame: 6 months ]

Original Primary Outcome Measures (submitted: June 11, 2012)

To assess Objective Response Rate in subjects treated with GTx-024 [ Time Frame: 6 months ]

Objective Response Rate is defined as the proportion of subjects with a complete response + partial response at 6 months as measured by modified RECIST 1.1

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase II Study of GTx024 in Women With Metastatic Breast Cancer
• 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
• Brief 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, and effects on tumor progression in women with Androgen Receptor positive breast cancer will also be assessed.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Metastatic Breast Cancer

Intervention

Drug: GTx-024 9mg

Other Name: GTx-024 dosage of three soft gels once daily to equal 9mg

Study Arms

Experimental: GTx-024 9mg

GTx-024 dosage of three soft gels once daily to equal 9mg

Intervention: Drug: GTx-024 9mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2017): 22
• Original Estimated Enrollment (submitted: June 11, 2012): 89
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

1. Give voluntary, signed informed consent in accordance with institutional policies.
2. Be a woman that has been diagnosed with ER positive metastatic breast cancer.
3. 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.
4. 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).
5. 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.
6. 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.
7. 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.
8. Serum creatinine 2.0 mg/dL
9. Have ECOG score 2.
10. Be age 18 years.

Exclusion Criteria

Subjects with any of the following will NOT be eligible for enrollment in this study:

1. Have triple negative breast cancer
2. 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
3. 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)
4. Untreated congestive heart failure or untreated angina
5. Have Stage 4 chronic obstructive pulmonary disease (COPD)
6. 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
7. 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
8. Have positive screen for hepatitis A antibody IgM or HIV
9. 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
10. 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).
11. Have untreated or uncontrolled brain metastasis
12. Have been diagnosed with or treated for cancer within the previous two years, other than breast cancer or non-melanoma carcinoma of the skin.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01616758
• Other Study ID Numbers: G200801
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: GTx
• Original Responsible Party: Same as current
• Current Study Sponsor: GTx
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: GTx
• Verification Date: March 2017