Trial Outcomes & Findings for Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer (NCT NCT04635059)
NCT ID: NCT04635059
Last Updated: 2025-11-17
Results Overview
PSA progression-free survival is defined as the length of time that a subject will be alive and free from PSA progression per PCWG3 guidelines.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Six months
Results posted on
2025-11-17
Participant Flow
Participant milestones
| Measure |
Pacritinib
Pacritinib is an oral drug.
Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pacritinib for Biochemical Relapse After Definitive Treatment for Prostate Cancer
Baseline characteristics by cohort
| Measure |
Pacritinib
n=6 Participants
Pacritinib is an oral drug.
Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=202 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=202 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=202 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=202 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=202 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=202 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=202 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=202 Participants
|
PRIMARY outcome
Timeframe: Six monthsPSA progression-free survival is defined as the length of time that a subject will be alive and free from PSA progression per PCWG3 guidelines.
Outcome measures
| Measure |
Pacritinib
n=6 Participants
Pacritinib is an oral drug.
Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
|
|---|---|
|
The Number of Patients With Six-month PSA Progression-free Survival.
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle1Day1 (month 0), every month up to month 4.Population: Two subjects were not tested in month 4.
PSA level in blood is measured in units of nanograms per milliliter.
Outcome measures
| Measure |
Pacritinib
n=6 Participants
Pacritinib is an oral drug.
Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
|
|---|---|
|
PSA Levels
PSA at C1D1 (month 0), ng/mL
|
1.9 ng/mL
Standard Deviation .5
|
|
PSA Levels
PSA at month 1, ng/mL
|
3.2 ng/mL
Standard Deviation .8
|
|
PSA Levels
PSA at month 2, ng/mL
|
4.1 ng/mL
Standard Deviation 1.3
|
|
PSA Levels
PSA at month 3, ng/mL
|
4.7 ng/mL
Standard Deviation .8
|
|
PSA Levels
PSA at month 4, ng/mL
|
5.7 ng/mL
Standard Deviation .3
|
SECONDARY outcome
Timeframe: Baseline and three monthsPopulation: Two subjects were not tested in month 3.
Serum testosterone will be measured in nanograms per deciliter.
Outcome measures
| Measure |
Pacritinib
n=6 Participants
Pacritinib is an oral drug.
Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
|
|---|---|
|
Testosterone Measurement
Testosterone at screening, ng/dL
|
390 ng/dL
Standard Deviation 280
|
|
Testosterone Measurement
Testosterone at 3 months, ng/dL
|
330 ng/dL
Standard Deviation 181
|
Adverse Events
Pacritinib
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pacritinib
n=6 participants at risk
Pacritinib is an oral drug.
Pacritinib: Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
|
|---|---|
|
Gastrointestinal disorders
Salivary duct inflammation
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Sinus bradycardia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Endocrine disorders
Testosterone deficiency
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Infections and infestations
Tooth infection
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Urinary frequency
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Urinary incontinence
|
50.0%
3/6 • Number of events 3 • 2 Years
|
|
Renal and urinary disorders
Urinary retention
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Urinary tract infection
|
50.0%
3/6 • Number of events 3 • 2 Years
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
White blood cell decreased
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 2 • 2 Years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Bladder spasm
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Belching
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Chronic kidney disease
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Psychiatric disorders
Depression
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 5 • 2 Years
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Ear and labyrinth disorders
Ear pain
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
General disorders
Edema limbs
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Eye disorders
Heavy eyelids
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
General disorders
Fatigue
|
100.0%
6/6 • Number of events 6 • 2 Years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Renal and urinary disorders
Hematuria
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • Number of events 2 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
83.3%
5/6 • Number of events 5 • 2 Years
|
|
Vascular disorders
Hypertension
|
100.0%
6/6 • Number of events 6 • 2 Years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Respiratory, thoracic and mediastinal disorders
COVID-19
|
50.0%
3/6 • Number of events 3 • 2 Years
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Lethargy
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Metabolism and nutrition disorders
Obesity
|
50.0%
3/6 • Number of events 3 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
3/6 • Number of events 3 • 2 Years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • 2 Years
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place