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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
Results First Posted : October 30, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
GTx

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Triple Negative Breast Cancer
Intervention Drug: GTx-024
Enrollment 32
Recruitment Details Up to 55 patients were planned for enrollment
Pre-assignment Details No patients were excluded from the study before drug assignment
Arm/Group Title GTx-024
Hide Arm/Group Description

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Period Title: Overall Study
Started 32 [1]
Completed 0
Not Completed 32
Reason Not Completed
Death             13
Lack of Efficacy             15
Physician Decision             4
[1]
32 subjects were enrolled and received at least one dose of study drug
Arm/Group Title GTx-024
Hide Arm/Group Description

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
65
(35 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
32
 100.0%
Male
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Caucasian Number Analyzed 32 participants
27
  84.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
 100.0%
AR status-positive  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
18
1.Primary Outcome
Title Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor Positive (AR+) Subjects
Hide Description 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.
Time Frame Sixteen (16) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were centrally confirmed as AR+
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
1
   5.6%
2.Secondary Outcome
Title Clinical Benefit Rate, in Full Analysis Set
Hide Description 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.
Time Frame Sixteen (16) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects, regardless of AR status
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
2
3.Secondary Outcome
Title Best Overall Response
Hide Description 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.
Time Frame From treatment initiation to end of treatment (up through 11 months of treatment, median duration of treatment 1.9 months).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
6
4.Secondary Outcome
Title Progression Free Survival
Hide Description 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 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
Hide Outcome Measure Data
Hide Analysis Population Description
All patients regardless of AR status
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
1.9
(1.7 to 2.3)
5.Secondary Outcome
Title Time-to-progression
Hide Description 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.
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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects regardless of AR status
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: months
1.9
(1.7 to 2.0)
6.Secondary Outcome
Title Duration of Response
Hide Description To assess the duration of response defined as the time from documentation of tumor response to disease progression or death
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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects regardless of AR status
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Median (Full Range)
Unit of Measure: months
1.9
(0.1 to 11)
7.Secondary Outcome
Title Objective Response Rate
Hide Description To estimate the objective response rate (defined as complete response or partial response) according to RECIST 1.1.
Time Frame Sixteen (16) weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
0
8.Other Pre-specified Outcome
Title Number of Participants With Adverse Events
Hide Description To describe the safety profile in subjects with TNBC and centrally confirmed AR+ as well as in all subjects enrolled and treated.
Time Frame Up to twelve (12) months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GTx-024
Hide Arm/Group Description:

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
28
Time Frame one year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GTx-024
Hide Arm/Group Description

GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg

All-Cause Mortality
GTx-024
Affected / at Risk (%)
Total   13/32 (40.63%)    
Hide Serious Adverse Events
GTx-024
Affected / at Risk (%) # Events
Total   5/32 (15.63%)    
Cardiac disorders   
CHF  1  1/32 (3.13%)  1
pleural effusion  2  1/32 (3.13%)  1
Gastrointestinal disorders   
constipation  2  1/32 (3.13%)  1
Metabolism and nutrition disorders   
dehydration  2  1/32 (3.13%)  1
Musculoskeletal and connective tissue disorders   
rib fracture  2  1/32 (3.13%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
tumor flare  2  1/32 (3.13%)  1
Renal and urinary disorders   
UTI  2  1/32 (3.13%)  1
Vascular disorders   
pulmonary embolism  2  1/32 (3.13%)  1
1
Term from vocabulary, CTCAE 4.0
2
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GTx-024
Affected / at Risk (%) # Events
Total   28/32 (87.50%)    
Blood and lymphatic system disorders   
blood disorder  2  4/32 (12.50%)  4
Gastrointestinal disorders   
GI  2  8/32 (25.00%)  8
Investigations   
investigations * 1  13/32 (40.63%)  13
Metabolism and nutrition disorders   
metabolism  2  8/32 (25.00%)  8
Nervous system disorders   
nervous system  2  3/32 (9.38%)  3
Skin and subcutaneous tissue disorders   
rash  2  3/32 (9.38%)  3
1
Term from vocabulary, CTCAE (Unspecified)
2
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Early termination due to lack of efficacy and limited data reported.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mary Breitmeyer
Organization: Oncternal
Phone: 858-434-1113
EMail: MBreitmeyer@oncternal.com
Layout table for additonal information
Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT02368691    
Other Study ID Numbers: G200901
First Submitted: February 10, 2015
First Posted: February 23, 2015
Results First Submitted: September 13, 2020
Results First Posted: October 30, 2020
Last Update Posted: November 18, 2020