Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02368691|
Recruitment Status : Terminated (Lack of Efficacy)
First Posted : February 23, 2015
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: GTx-024||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 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 AR+ subjects [ Time Frame: Sixteen (16) weeks ]To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1 in subjects with centrally confirmed AR+ status
- 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.
- Clinical benefit rate [ Time Frame: Twenty-four (24) weeks ]To estimate the proportion of subjects who achieve clinical benefit
- Objective response rate [ Time Frame: Twenty-four (24) weeks ]To estimate the objective response rate (defined as complete response or partial response) according to RECIST 1.1.
- Best overall response [ Time Frame: From treatment initiation to end of treatment ]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.
- Progression free survival [ Time Frame: From treatment initiation to tumor progression or death ]To assess progression free survival 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 ]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 ]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.
- Overall survival [ Time Frame: Up to twenty-four (24) months ]To estimate overall survival defined as the time from treatment initiation until death or date of last follow up to a maximum of 24 months post treatment initiation.
- Number of 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.
- Pharmacokinetic assessment [ Time Frame: Up to twelve (12) months ]To describe the plasma concentrations of GTx-024 and GTx-024 glucuronide at each of the assessed time points.
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|