Trial Outcomes & Findings for Phase II Study of GTx024 in Women With Metastatic Breast Cancer (NCT NCT01616758)

NCT ID: NCT01616758

Last Updated: 2024-03-08

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 22 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-03-08

Participant Flow

Participant milestones

Measure	GTx-024 9mg GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Overall Study STARTED	22
Overall Study Evaluable	20
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Measure	GTx-024 9mg GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	2
Overall Study Disease progression	18
Overall Study Study termination by Sponsor	1

Baseline Characteristics

Phase II Study of GTx024 in Women With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	GTx-024 9mg n=22 Participants GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Age, Customized ≥18 years	22 Participants n=5 Participants
Sex/Gender, Customized Female	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: ITT population

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).

Outcome measures

Measure	GTx-024 9mg n=17 Participants GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Percentage of Subjects Treated With GTx024 With Clinical Benefit With AR Positive Breast Cancer	6 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: ITT population

Clinical Benefit is defined as a complete response (CR), partial response (PR), or stable disease (SD).

Outcome measures

Measure	GTx-024 9mg n=22 Participants GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Percentage of Subjects Treated With GTx024 With Clinical Benefit (All Subjects)	7 Participants

SECONDARY outcome

Timeframe: 1 Year

Population: ITT population

Objective Response is defined as achieving Complete or Partial Response on Tumor Assessments

Note: Due to zero subject achieving response, all subsequent outcome measures related to response cannot be conducted.

Outcome measures

Measure	GTx-024 9mg n=22 Participants GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Percentage of Subjects Treated With GTx024 Achieving Objective Response by 1 Year of Treatment	0 Participants

Adverse Events

GTx-024 9mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	GTx-024 9mg n=22 participants at risk GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Musculoskeletal and connective tissue disorders Pathologic Hip Fracture	4.5% 1/22 • Number of events 1
Musculoskeletal and connective tissue disorders Bone pain of Chest	4.5% 1/22 • Number of events 1

Other adverse events

Measure	GTx-024 9mg n=22 participants at risk GTx-024 dosage of three soft gels once daily to equal 9mg GTx-024 9mg
Gastrointestinal disorders Diarrhoea	18.2% 4/22
Gastrointestinal disorders Nausea	36.4% 8/22
General disorders Fatigue	36.4% 8/22
Musculoskeletal and connective tissue disorders Arthralgia	27.3% 6/22
Musculoskeletal and connective tissue disorders Back pain	27.3% 6/22
Musculoskeletal and connective tissue disorders Muscle Spasms	13.6% 3/22
Nervous system disorders Headache	18.2% 4/22
Vascular disorders Hot Flush	27.3% 6/22

Additional Information

Mary Bretimeyer

Oncternal Therapeutics

Phone: 8582092082

Email: mbreitmeyer@oncternal.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place