Trial Outcomes & Findings for Addition of Opaganib to Androgen Antagonists in Patients With mCRPC (NCT NCT04207255)

NCT ID: NCT04207255

Last Updated: 2024-09-25

Results Overview

Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

69 participants

Primary outcome timeframe

113 days

Results posted on

2024-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 2: Opaganib With Abiraterone Opaganib: 500mg of Opaganib orally twice a day continuously. Abiraterone: IV as directed by SOC	Cohort 3: Opaganib With Enzalutamide Opaganib: 500mg of Opaganib orally twice a day continuously. Enzalutamide: IV as directed by SOC	Cohort 1a: Opaganib With Abiraterone Abiraterone: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.	Cohort 1b: Opaganib With Enzalutamide Enzalutamide: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.
Overall Study STARTED	27	36	3	3
Overall Study COMPLETED	27	36	3	3
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Addition of Opaganib to Androgen Antagonists in Patients With mCRPC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 2: Opaganib With Abiraterone n=27 Participants Opaganib: 500mg of Opaganib orally twice a day continuously. Abiraterone: IV as directed by SOC	Cohort 3: Opaganib With Enzalutamide n=36 Participants Opaganib: 500mg of Opaganib orally twice a day continuously. Enzalutamide: IV as directed by SOC	Cohort 1a: Opaganib With Abiraterone n=3 Participants Abiraterone: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.	Cohort 1b: Opaganib With Enzalutamide n=3 Participants Enzalutamide: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.	Total n=69 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	11 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	16 Participants n=21 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	25 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	53 Participants n=21 Participants
Age, Continuous	71 years n=5 Participants	71 years n=7 Participants	67 years n=5 Participants	71 years n=4 Participants	71 years n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	36 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	69 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 Participants n=5 Participants	34 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	65 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	26 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	49 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 113 days

Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment

Outcome measures

Outcome measures
Measure	Cohort 2: Opaganib With Abiraterone n=27 Participants Opaganib: 500mg of Opaganib orally twice a day continuously. Abiraterone: IV as directed by SOC	Cohort 3: Opaganib With Enzalutamide n=36 Participants Opaganib: 500mg of Opaganib orally twice a day continuously. Enzalutamide: IV as directed by SOC	Cohort 1a: Opaganib With Abiraterone n=3 Participants Abiraterone: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.	Cohort 1b: Opaganib With Enzalutamide n=3 Participants Enzalutamide: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.
Disease Control Status	4 Participants	3 Participants	0 Participants	0 Participants

Adverse Events

Cohort 2: Opaganib With Abiraterone

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Cohort 3: Opaganib With Enzalutamide

Serious events: 11 serious events

Other events: 36 other events

Deaths: 1 deaths

Cohort 1a: Opaganib With Abiraterone

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 1b: Opaganib With Enzalutamide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 2: Opaganib With Abiraterone n=27 participants at risk Opaganib: 500mg of Opaganib orally twice a day continuously. Abiraterone: IV as directed by SOC	Cohort 3: Opaganib With Enzalutamide n=36 participants at risk Opaganib: 500mg of Opaganib orally twice a day continuously. Enzalutamide: IV as directed by SOC	Cohort 1a: Opaganib With Abiraterone n=3 participants at risk Abiraterone: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.	Cohort 1b: Opaganib With Enzalutamide n=3 participants at risk Enzalutamide: IV as directed by SOC Opaganib: 250mg of Opaganib orally twice a day continuously.
Nervous system disorders Seizure	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Vascular disorders Hematoma	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Cardiac disorders Ventricular Dysrythmia	3.7% 1/27 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/36 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Nervous system disorders Stroke	3.7% 1/27 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/36 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/36 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Cardiac disorders Hypertension	3.7% 1/27 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/36 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Vascular disorders Subdural Hemorrhage	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Cardiac disorders Myocardial Infarction	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Infections and infestations Sepsis	0.00% 0/27 • 2 years, 9 months, 23 days	5.6% 2/36 • Number of events 2 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Renal and urinary disorders Urinary Tract Infection	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
General disorders Dehydration	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days
Nervous system disorders Edema cerebral	0.00% 0/27 • 2 years, 9 months, 23 days	2.8% 1/36 • Number of events 1 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days	0.00% 0/3 • 2 years, 9 months, 23 days

Other adverse events

Additional Information

Alan Brisendine

Medical University of South Carolina

Phone: (843) 792-9007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place