Phase II Study of GTx024 in Women With Metastatic Breast Cancer

NCT01616758 | Terminated Phase 2 Results

• 1 other identifier: G200801
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

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.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  6 months

Secondary Outcomes (2)

• Percentage of Subjects Treated With GTx024 With Clinical Benefit (All Subjects)

  6 Months

• Percentage of Subjects Treated With GTx024 Achieving Objective Response by 1 Year of Treatment

  1 Year

Study Arms (1)

GTx-024 9mg

EXPERIMENTAL

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

Drug: GTx-024 9mg

Interventions

GTx-024 9mg DRUG

Also known as: GTx-024 dosage of three soft gels once daily to equal 9mg

GTx-024 9mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• GTx: lead

Study Sites (4)

AMPM Research Clinic

Miami, Florida, 33145, United States

Location

Illinois Cancer Care, PC

Peoria, Illinois, 61615, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02110, United States

Location

Commonwealth Hematology-Oncology

Lawrence, Massachusetts, 01841, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ostarine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Mary Bretimeyer
• Organization: Oncternal Therapeutics

mbreitmeyer@oncternal.com

8582092082

Study Officials

• Mayzie Johnston, PharmD

  GTx

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2012
• First Posted: June 12, 2012
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: March 1, 2016
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Locations

US (4)