Clinical Trial: Efficacy and Safety of GTx-024 in Patients With Androgen Receptor-Positive Triple Negative Breast Cancer (AR+ TNBC)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Can

Brief Summary: The purpose of this study is to determine if GTx-024 is effective and safe in the treatment of patients with advanced, androgen receptor positive triple negative breast cancer (AR+ TNBC).

Detailed Summary:
Sponsor: GTx

Current Primary Outcome: 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


Original Primary Outcome: Clinical benefit rate with TNBC and centrally confirmed AR+ status. [ Time Frame: Sixteen (16) weeks ]

To estimate the proportion of women with TNBC and centrally confirmed AR+ status who achieve clinical benefit (defined as complete response, partial response, or stable disease) according to RECIST 1.1


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Clinical benefit rate [ Time Frame: Sixteen (16) weeks ]
    To estimate the proportion of women with TNBC, regardless of central confirmation of AR status, who achieve clinical benefit.
  • Clinical benefit rate [ Time Frame: Twenty-four (24) weeks ]
    To estimate the proportion of women with TNBC who achieve clinical benefit
  • Overall response rate [ Time Frame: Sixteen (16) weeks ]
    To estimate the overall response rate (defined as complete response or partial response) according to RECIST 1.1.
  • Overall response rate [ Time Frame: Twenty-four (24) weeks ]
    To estimate the overall response rate (defined as complete response or partial response) according to RECIST 1.1.
  • Best overall response [ Time Frame: Up to twelve (12) 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.
  • Progression free survival [ Time Frame: Up to twelve (12) months ]
    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: Up to twelve (12) 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: Up to twelve (12) months ]
    To assess the duration of response defined as the time from documentation of tumor response to disease progression or death


Information By: GTx

Dates:
Date Received: February 10, 2015
Date Started: June 2015
Date Completion: November 2017
Last Updated: August 30, 2016
Last Verified: August 2016