Trial Outcomes & Findings for Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (NCT NCT03413995)

Last Updated: 2024-10-16

Results Overview

Response Rate(PSA) Prostate Specific Antigen to rucaparib for patients with metastatic hormone sensitive prostate cancer harboring germline mutation in homologous recombination DNA (Deoxyribonucleic acid) repair gene. Measured by decline in PSA to 50% of baseline, confirmed with second measurement at least 4 weeks apart.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

4 weeks

Results posted on

2024-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Rucaparib 600 mg BID Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rucaparib 600 mg BID, Continuous Dosing n=12 Participants Rucaparib 600mg by mouth twice daily, continuous dosing Rucaparib: Continuous dosing
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	12 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	12 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	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Rucaparib 600 mg BID n=12 Participants Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Number of Participants With Prostate Specific Antigen (PSA) >=50 Response	5 Participants

SECONDARY outcome

Timeframe: 4 years 8 months

As assessed by CTCAE v4.0

Outcome measures

Outcome measures
Measure	Rucaparib 600 mg BID n=12 Participants Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Number of Participants With Treatment-related Adverse Events	12 Participants

SECONDARY outcome

Timeframe: 2 years

Defined as a time (months) from initiation of rucaparib therapy until PSA increase of 25 %, confirmed with another measurement at least 3 weeks later

Outcome measures

Outcome measures
Measure	Rucaparib 600 mg BID n=12 Participants Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
PSA Progression-free Survival	11.2 months Interval 3.7 to Upper bound is not reached because there is not sufficient number of patients who have had PSA PFS events.

SECONDARY outcome

Timeframe: 2 years

Defined as time (months) from initiation of rucaparib therapy to radiographic or clinical progression or death, whichever comes first.

Outcome measures

Outcome measures
Measure	Rucaparib 600 mg BID n=12 Participants Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Progression-free Survival	12 months Interval 8.0 to Upper bound is not reached because there is not sufficient number of patients who have had PSA PFS events.

SECONDARY outcome

Timeframe: 2 years

Population: Of the 12 subjects enrolled in the trial, 5 of them had measurable disease. Therefore, for this outcome, 5 were included in this outcome analysis.

Defined as patients achieving a complete or partial response in target lesions found on radiographic scans among patients who have measurable disease at baseline.

Outcome measures

Outcome measures
Measure	Rucaparib 600 mg BID n=5 Participants Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Objective Response	3 Participants

Adverse Events

Rucaparib 600 mg BID

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rucaparib 600 mg BID n=12 participants at risk Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Gastrointestinal disorders Small Bowel Obstruction	8.3% 1/12 • Number of events 1 • Baseline to End of Treatment approximately 4 years 8 months
Cardiac disorders Atrial Fibrillation	8.3% 1/12 • Number of events 1 • Baseline to End of Treatment approximately 4 years 8 months
Respiratory, thoracic and mediastinal disorders Pneumonia	8.3% 1/12 • Number of events 1 • Baseline to End of Treatment approximately 4 years 8 months

Other adverse events

Other adverse events
Measure	Rucaparib 600 mg BID n=12 participants at risk Subjects will be administered Rucaparib 600mg by mouth twice daily, continuous dosing in 28 day cycles. Drug should be taken as close as possible to 12 hours apart and preferably at the same times every day, with water. Rucaparib tablets must be swallowed whole and may be taken with or without food. Rucaparib: Rucaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Blood and lymphatic system disorders Aspartate Aminotransferase-increased	58.3% 7/12 • Number of events 7 • Baseline to End of Treatment approximately 4 years 8 months
Blood and lymphatic system disorders Alanine Aminotransferase-Increased	58.3% 7/12 • Number of events 7 • Baseline to End of Treatment approximately 4 years 8 months
Blood and lymphatic system disorders Creatinine-Increased	50.0% 6/12 • Number of events 6 • Baseline to End of Treatment approximately 4 years 8 months
General disorders Edema	8.3% 1/12 • Number of events 1 • Baseline to End of Treatment approximately 4 years 8 months
Gastrointestinal disorders Nausea	50.0% 6/12 • Number of events 6 • Baseline to End of Treatment approximately 4 years 8 months
General disorders Fatigue	66.7% 8/12 • Number of events 8 • Baseline to End of Treatment approximately 4 years 8 months
Nervous system disorders Dysguesia	41.7% 5/12 • Number of events 5 • Baseline to End of Treatment approximately 4 years 8 months
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Baseline to End of Treatment approximately 4 years 8 months
Gastrointestinal disorders Diarrhea	33.3% 4/12 • Number of events 4 • Baseline to End of Treatment approximately 4 years 8 months
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodyesia Syndrome	16.7% 2/12 • Number of events 2 • Baseline to End of Treatment approximately 4 years 8 months
Blood and lymphatic system disorders Anemia	33.3% 4/12 • Number of events 4 • Baseline to End of Treatment approximately 4 years 8 months
Skin and subcutaneous tissue disorders Skin Rash	16.7% 2/12 • Number of events 2 • Baseline to End of Treatment approximately 4 years 8 months

Additional Information

Mark Markowski, MD

Johns Hopkins University

Phone: 410-614-0567

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place