Trial Outcomes & Findings for GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer (NCT NCT01420861)

NCT ID: NCT01420861

Last Updated: 2023-10-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2023-10-06

Participant Flow

18 subjects were enrolled with 7 subjects screen failing and 2 subjects randomized but not treated, for a total of 11 subjects treated. Outputs generated from previous company only provided data for the 11 subjects randomized. Program was halted.

Participant milestones

Measure	1000 mg GTx-758 BID subjects will receive daily doses of 1000 mg GTx-758 GTx-758: two GTx 758 tablets per day
Overall Study STARTED	18
Overall Study Randomized	11
Overall Study Treated	9
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Measure	1000 mg GTx-758 BID subjects will receive daily doses of 1000 mg GTx-758 GTx-758: two GTx 758 tablets per day
Overall Study Adverse Event	2
Overall Study Study terminated by Sponsor	7
Overall Study Screen failure	7
Overall Study Randomized not Treated	2

Baseline Characteristics

GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	1000 mg GTx-758 BID n=9 Participants subjects will receive daily doses of 1000 mg GTx-758 GTx-758: two GTx 758 tablets per day
Age, Continuous	73.3 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex/Gender, Customized Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Treated Patients

Outcome measures

Measure	1000 mg GTx-758 BID n=9 Participants subjects will receive daily doses of 1000 mg GTx-758 GTx-758: two GTx 758 tablets per day
Decline in Serum PSA 2 consecutive 50% or more decline	3 Participants
Decline in Serum PSA 1 50% or more decline without confirmation in next visit	1 Participants
Decline in Serum PSA No 50% or more decline observed	5 Participants

Adverse Events

1000 mg GTx-758 BID

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	1000 mg GTx-758 BID n=9 participants at risk subjects will receive daily doses of 1000 mg GTx-758 GTx-758: two GTx 758 tablets per day
Nervous system disorders Stroke	11.1% 1/9 • Number of events 1

Other adverse events

Measure	1000 mg GTx-758 BID n=9 participants at risk subjects will receive daily doses of 1000 mg GTx-758 GTx-758: two GTx 758 tablets per day
Gastrointestinal disorders Diarrhoea	22.2% 2/9
Gastrointestinal disorders Gastroesophageal Reflux Disease	22.2% 2/9
Gastrointestinal disorders Vomiting	22.2% 2/9
General disorders Chills	22.2% 2/9

Additional Information

Mary Breitmeyer

Oncternal Therapeutics

Phone: 8582092082

Email: mbreitmeyer@oncternal.com

Results disclosure agreements

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