Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)
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|ClinicalTrials.gov Identifier: NCT02368691|
Recruitment Status : Terminated (Lack of Efficacy)
First Posted : February 23, 2015
Results First Posted : October 30, 2020
Last Update Posted : November 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: GTx-024||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open Label, Multi-Center, Multinational Study Investigating The Efficacy and Safety Of GTx-024 On Advanced, Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||September 22, 2017|
|Actual Study Completion Date :||September 22, 2017|
GTx-024 capsules, 18 mg PO once-daily for up to 12 months
GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg
- Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor Positive (AR+) Subjects [ Time Frame: Sixteen (16) weeks ]To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST) as assessed by CT or MRI in subjects with centrally confirmed AR+ status. Clinical Benefit Rate=CR+PR+SD. Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, <30% decrease in sum of the longest diameter of target lesions.
- Clinical Benefit Rate, in Full Analysis Set [ Time Frame: Sixteen (16) weeks ]To estimate the clinical benefit rate in all subjects who receive at least one dose of study medication (full analysis set), regardless of central confirmation of AR status.
- Best Overall Response [ Time Frame: From treatment initiation to end of treatment (up through 11 months of treatment, median duration of treatment 1.9 months). ]To assess best overall response as measured by RECIST 1.1 from the start of study treatment until the end of treatment taking into account any requirement for confirmation. Best overall response is reported as the best response (CR, PR or SD) by CT or MRI up through 11 months of treatment, median duration of treatment 1.9 months.
- Progression Free Survival [ Time Frame: From treatment initiation to tumor progression or death. PFS was assessed up to 11 months of treatment; median duration of treatment, 1.9 months ]To assess progression free survival (PFS) defined as the time elapsed between initiation of treatment and tumor progression as measured by RECIST 1.1 or death.
- Time-to-progression [ Time Frame: From treatment initiation to tumor progression or death. Time to progression was assessed up to 11 months of treatment; median duration of treatment, 1.9 months ]To assess time to progression defined as time elapsed between treatment initiation and tumor progression as measured by RECIST 1.1 or death due to disease progression.
- Duration of Response [ Time Frame: From time of documented tumor response to tumor progression or death. Duration of response was assessed through 11 months; median treatment duration, 1.9 months ]To assess the duration of response defined as the time from documentation of tumor response to disease progression or death
- Objective Response Rate [ Time Frame: Sixteen (16) weeks ]To estimate the objective response rate (defined as complete response or partial response) according to RECIST 1.1.
- Number of Participants With Adverse Events [ Time Frame: Up to twelve (12) months ]To describe the safety profile in subjects with TNBC and centrally confirmed AR+ as well as in all subjects enrolled and treated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02368691
|United States, Florida|
|Holy Cross Hospital|
|Fort Lauderdale, Florida, United States, 33308|
|Lakeland Regional Health Care/Cancer Center|
|Lakeland, Florida, United States, 33805|
|University of Miami Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|United States, Montana|
|St. Vincent Frontier Cancer Center|
|Billings, Montana, United States, 59102|
|United States, Tennessee|
|The West Clinic, PC|
|Memphis, Tennessee, United States, 38120|
|United States, Texas|
|US Oncology / Texas Oncology, P.A.|
|Houston, Texas, United States, 77024|
|Principal Investigator:||Hope S Rugo, MD||University of California, San Francisco|