Trial Outcomes & Findings for Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC) (NCT NCT02500901)
NCT ID: NCT02500901
Last Updated: 2019-10-21
Results Overview
MTD of niraparib in combination with enzalutamide and MTD for phase II testing.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
From the start of combination treatment D29 until 30 days after last dose of study treatment per CTCAE v4, assessed up to 52 weeks
Results posted on
2019-10-21
Participant Flow
Participant milestones
| Measure |
Experimental Treatment
enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.
Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Experimental Treatment
enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.
Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented
|
|---|---|
|
Overall Study
Disease ProgressionDD
|
2
|
Baseline Characteristics
Enzalutamide and Niraparib in the Treatment of Metastatic Castrate-Resistant Prostate Cancer (CRPC)
Baseline characteristics by cohort
| Measure |
Experimental Treatment
n=2 Participants
Enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.
Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented
|
|---|---|
|
Age, Continuous
|
77 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 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
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2 participants
n=5 Participants
|
|
Eastern Cooperative Group (ECOG) Performance Status
ECOG 0
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1 Participants
n=5 Participants
|
|
Eastern Cooperative Group (ECOG) Performance Status
ECOG 1
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1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of combination treatment D29 until 30 days after last dose of study treatment per CTCAE v4, assessed up to 52 weeksPopulation: Sufficient data was not collected to determine the maximum tolerated dose (MTD) before study termination.
MTD of niraparib in combination with enzalutamide and MTD for phase II testing.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of enrollment until the criteria for disease progression is met as defined by RECIST 1.1 or death from any cause, whichever occurs first, assessed up to 52 weeksPopulation: Sufficient data was not collected or analyzed for this secondary objective before study termination.
PFS per RECIST v1.1 for subjects on this combination therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of enrollment until the date of documented disease progression or the date of death from any cause, whichever occurs first, assessed up to 52 weeksPopulation: Sufficient data was not collected or analyzed for this secondary objective before study termination.
OR outcomes for subjects on this combination therapy, per RECIST v1.1
Outcome measures
Outcome data not reported
Adverse Events
Experimental Treatment
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Treatment
n=2 participants at risk
enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.
Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented
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|---|---|
|
Injury, poisoning and procedural complications
FALL
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
Other adverse events
| Measure |
Experimental Treatment
n=2 participants at risk
enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.
Enzalutamide: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
Niraparib: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented
|
|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
50.0%
1/2 • Number of events 5 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
BUTTOCK PAIN
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Gastrointestinal disorders
CONSTIPATION
|
100.0%
2/2 • Number of events 2 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Investigations
CREATININE INCREASED
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Gastrointestinal disorders
DIARRHEA
|
100.0%
2/2 • Number of events 4 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Nervous system disorders
DIZZINESS
|
50.0%
1/2 • Number of events 2 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Gastrointestinal disorders
DRY MOUTH
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
50.0%
1/2 • Number of events 3 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
General disorders
EDEMA LIMBS
|
100.0%
2/2 • Number of events 3 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
General disorders
FATIGUE
|
100.0%
2/2 • Number of events 3 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Nervous system disorders
HEADACHE
|
50.0%
1/2 • Number of events 2 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Vascular disorders
HYPERTENSION
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Metabolism and nutrition disorders
HYPERURICEMIA
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
NAIL DISCOLORATION
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Gastrointestinal disorders
NAUSEA
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
RASH ACNEIFORM
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Skin and subcutaneous tissue disorders
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Vascular disorders
THROMBOEMBOLIC EVENT
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Investigations
WEIGHT LOSS
|
50.0%
1/2 • Number of events 1 • Duration of participation in study, or until disease progression, up to 24 months.
|
|
Investigations
WHITE BLOOD CELL DECREASED
|
50.0%
1/2 • Number of events 2 • Duration of participation in study, or until disease progression, up to 24 months.
|
Additional Information
Clinicaltrials.gov Results Coordinator
Hoosier Cancer Research Network
Phone: 317-643-5842
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place