Trial Outcomes & Findings for Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer (NCT NCT03999515)

Last Updated: 2023-09-28

Results Overview

Will be calculated as the percentage of patients, with 95% confidence intervals, achieving a complete response or partial response across the entire study population at any time.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Up to 67 days

Results posted on

2023-09-28

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=3 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized White, Non Hispanic	3 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 67 days

Population: Enrolled patients who had re-staging scans performed. Note, study was terminated early due to low accrual.

Will be calculated as the percentage of patients, with 95% confidence intervals, achieving a complete response or partial response across the entire study population at any time.

Outcome measures

Outcome measures
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=2 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Objective Response Rate	0 Participants

SECONDARY outcome

Timeframe: Up to 67 days

Population: Enrolled patients who had re-staging scans performed. Note, study was terminated early due to low accrual.

Progression free survival is time to progressive disease. Disease progression is determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for soft tissue metastases and Prostate Cancer Working Group 3 criteria for bone metastases. Median progression free survival will be calculated.

Outcome measures

Outcome measures
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=2 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Radiographic Progression Free Survival (PFS)	59 days Interval 59.0 to 67.0

SECONDARY outcome

Timeframe: Up to 67 days

Population: Enrolled patients who had re-staging scans performed. Note, study was terminated early due to low accrual.

Time to response is the time until a radiographic response occures as determined by RECIST 1.1 criteria. This cannot be determined since only two patients had re-staging scans on study and neither had a response.

Outcome measures

Outcome measures
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=2 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Time to Response	NA years 0 patients achieved a response and therefore time to response cannot be calculated.

SECONDARY outcome

Timeframe: From cycle 1, day 1 to the date of death, assessed up to 178 days

Population: Note, study was terminated early due to low accrual.

Overall survival is time to death from any cause. Median overall survival survival will be calculated.

Outcome measures

Outcome measures
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=3 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Overall Survival (OS)	94 days Interval 40.0 to 178.0

SECONDARY outcome

Timeframe: Baseline up to 73 days

Population: Enrolled patients who had repeat PSA performed while on study. Note, study was terminated early due to low accrual.

PSA response will be defined by a \> 50% reduction in PSA compared with baseline at any point during treatment. We will report the percentage of patients who achieve a PSA response.

Outcome measures

Outcome measures
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=2 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Prostate-specific Antigen (PSA) Response	0 Participants

SECONDARY outcome

Timeframe: Within 14 days of end of treatment, an average of 1 year.

Will be assessed using version National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will characterize AEs by type and grade. Safety will be summarized as the severity and frequency of a given AE.

Outcome measures

Outcome measures
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=3 Participants Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Incidence and Severity of Adverse Events (AEs)	3 Participants

Adverse Events

Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib)

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=3 participants at risk Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Metabolism and nutrition disorders Hypercalcemia	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Investigations Blood Bilirubin Increased	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year

Other adverse events

Other adverse events
Measure	Treatment (Abiraterone Acetate, Enzalutamide, Erdafitinib) n=3 participants at risk Patients receive abiraterone acetate orally PO QD or enzalutamide PO QD on days 1-21. Patients also receive erdafitinib PO QD on days 1-21. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Enzalutamide: Given PO Erdafitinib: Given PO
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 2 • Within 14 days of end of treatment, an average of 1 year
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Eye disorders Dry Eye	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
General disorders Fatigue	33.3% 1/3 • Number of events 3 • Within 14 days of end of treatment, an average of 1 year
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Investigations Weight Loss	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
Nervous system disorders Peripheral Motor Neuropathy	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
General disorders Nail Changes	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
General disorders Mouth Sores	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
General disorders Decreased Appetite	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year
General disorders Nasal Dryness	33.3% 1/3 • Number of events 1 • Within 14 days of end of treatment, an average of 1 year

Additional Information

Dr. Michael Schweizer

Fred Hutchinson Cancer Center

Phone: 2066066252

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place