Trial Outcomes & Findings for Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer (NCT NCT05501548)

Last Updated: 2025-01-29

Results Overview

Number of participants with metastatic castration resistance prostate cancer (mCRPC) who experience a 50% reduction in prostate specific antigen (PSA50) from baseline. PSA50 response will be defined as a decrease in the PSA to 50% less than the baseline PSA upon enrollment in the trial. The decrease must be confirmed by a second measurement at least 4 weeks apart. PSA values will be measured monthly during the trial.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

up to 5 years

Results posted on

2025-01-29

Participant Flow

Participant milestones

Participant milestones
Measure	Olaparib and Vitamin C Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons. Olaparib: Olaparib 300mg by mouth twice daily Vitamin C: Ascorbic acid 1g/kg administered intravenously twice weekly
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib and Vitamin C n=4 Participants Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons. Olaparib: Olaparib 300mg by mouth twice daily Vitamin C: Ascorbic acid 1g/kg administered intravenously twice weekly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	4 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	0 Participants n=5 Participants
Race (NIH/OMB) White	4 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
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: Data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 1 year 4 months

Number of participants experiencing treatment-related adverse events as defined by NCI CTCAE v5.0.

Outcome measures

Outcome measures
Measure	Olaparib and Vitamin C n=4 Participants Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons. Olaparib: Olaparib 300mg by mouth twice daily Vitamin C: Ascorbic acid 1g/kg administered intravenously twice weekly
Safety and Tolerability of Olaparib in Combination With IV Ascorbic Acid in Patients With mCRPC	4 Participants

SECONDARY outcome

Timeframe: up to 5 years

Population: Data was not collected for this outcome measure.

Median number of months to PSA doubling from the initiation of therapy until the PSA has increased to 200% of baseline value, and confirmed with another measurement at least 4 weeks later, or death. The date of PSA doubling will be the first value recorded (not the confirmatory value).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: Data was not collected for this outcome measure.

Number of months from initiation of therapy to date of first radiographic progression, death from any cause, or last patient evaluation. Radiographic progression will be defined as soft tissue disease progression by modified RECIST criteria 1.1 (baseline LN size must be \>1.0 cm to be considered target or evaluable lesion) or by development of two or more new bone lesions not consistent with tumor flair for prostate cancer working group 3.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: Data was not collected for this outcome measure.

Number of months to first PSA failure (two consecutive increases in PSA of 50% and \>=5ng/mL above nadir) or death

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 5 years

Population: Data was not collected for this outcome measure.

Number of months from initiation of therapy to death due to any cause

Outcome measures

Outcome data not reported

Adverse Events

Olaparib and Vitamin C

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Olaparib and Vitamin C n=4 participants at risk Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons. Olaparib: Olaparib 300mg by mouth twice daily Vitamin C: Ascorbic acid 1g/kg administered intravenously twice weekly
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
General disorders Non-cardiac chest pain	25.0% 1/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
Respiratory, thoracic and mediastinal disorders Productive cough	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Gastrointestinal disorders Abdominal pain	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Eye disorders Dry eye	50.0% 2/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
Psychiatric disorders Agitation	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
General disorders Fever	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
General disorders Chills	25.0% 1/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
Gastrointestinal disorders Nausea	100.0% 4/4 • Number of events 4 • From enrollment through study completion (approximately 1 year 4 months)
Vascular disorders Flushing	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Injury, poisoning and procedural complications Infusion related reaction	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
General disorders Fatigue	75.0% 3/4 • Number of events 3 • From enrollment through study completion (approximately 1 year 4 months)
Investigations Aspartate aminotransferase increased	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Investigations Alanine aminotransferase increased	25.0% 1/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Gastrointestinal disorders Hemorrhoidal hemorrhage	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Investigations Lymphocyte count decreased	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Gastrointestinal disorders Constipation	75.0% 3/4 • Number of events 3 • From enrollment through study completion (approximately 1 year 4 months)
General disorders Pain	50.0% 2/4 • Number of events 3 • From enrollment through study completion (approximately 1 year 4 months)
Injury, poisoning and procedural complications Bruising	50.0% 2/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
General disorders Edema limbs	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Skin and subcutaneous tissue disorders Skin ulceration	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Blood and lymphatic system disorders Anemia	50.0% 2/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
Investigations Weight loss	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Metabolism and nutrition disorders Anorexia	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)
Musculoskeletal and connective tissue disorders Flank pain	25.0% 1/4 • Number of events 2 • From enrollment through study completion (approximately 1 year 4 months)
Gastrointestinal disorders Dyspepsia	25.0% 1/4 • Number of events 1 • From enrollment through study completion (approximately 1 year 4 months)

Additional Information

Channing Paller, M.D., principal investigator

Johns Hopkins University

Phone: 410-955-8239

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place