Trial Outcomes & Findings for Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients (NCT NCT01705652)
NCT ID: NCT01705652
Last Updated: 2015-06-11
Results Overview
PSA decline to \< 1.0 ng/ml at 3 months post end of radiation or surgery
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
3 months post end of radiation treatment or surgery
Results posted on
2015-06-11
Participant Flow
Subjects were recruited from 7/20/2011 to 4/16/2013 from the ALM VA South Texas urology clinic.
Subjects were required to have a diagnosis of prostate cancer and treatment planned by surgery or radiation therapy.. Subjects were excluded if they were currently taking anticoagulation medications, or medications that are known to produce or are suspected of QT prolongation.
Participant milestones
| Measure |
Nexrutine Surgery Group
Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
|
Nexrutine Radiation Group
Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
12
|
|
Overall Study
COMPLETED
|
6
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
| Measure |
Nexrutine Surgery Group
Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
|
Nexrutine Radiation Group
Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
non-compliance
|
1
|
1
|
Baseline Characteristics
Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Nexrutine Surgery Group
n=9 Participants
Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery.
|
Nexrutine Radiation Group
n=12 Participants
Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
12 participants
n=7 Participants
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months post end of radiation treatment or surgeryPopulation: Radiation Group: One subject who did not complete the study was included as he did stay in the study through the 3 month post radiation treatment time period, and dropped out after that time.
PSA decline to \< 1.0 ng/ml at 3 months post end of radiation or surgery
Outcome measures
| Measure |
Radiation Group
n=10 Participants
Nexrutine by mouth three times per day for a minimum of 30 days and a maximum of 60 days prior to the start of radiation therapy and during treatment. The final dose will be taken the last day of radiation.
|
Surgery Group
n=6 Participants
Nexrutine by mouth three times per day prior to surgery for a minimum of 30 days and maximum of 80 days. The final dose is taken the day before surgery.
|
|---|---|---|
|
PSA (Prostate Specific Antigen)
|
2 participants
|
6 participants
|
Adverse Events
Nexrutine Surgery Group
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Nexrutine Radiation Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Nexrutine Surgery Group
n=9 participants at risk
Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
|
Nexrutine Radiation Group
n=12 participants at risk
Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
41.7%
5/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Blood and lymphatic system disorders
Anemia
|
77.8%
7/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
33.3%
4/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
75.0%
9/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
33.3%
4/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
25.0%
3/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
EKG QT corrected interval prolongation
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
General disorders
Edema limbs
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
General disorders
Fatigue
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
50.0%
6/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Nervous system disorders
Headache
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
3/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
33.3%
4/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hypotension
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Platelet count decreased
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
25.0%
3/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urine discoloration
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
16.7%
2/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Weight gain
|
0.00%
0/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
8.3%
1/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Aspatrate aminotransferase increased
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Bladder spasm
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Creatinine increased
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Psychiatric disorders
Depression
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Genital edema
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Vascular disorders
Hot flashes
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.2%
2/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
3/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
6/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Reproductive system and breast disorders
Pelvic pain
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Renal and urinary disorders
Urinary incontinence
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
|
Investigations
Weight loss
|
11.1%
1/9 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
0.00%
0/12 • During Treatment plus 30 days.
Regular investigator assessment, regular laboratory testing
|
Additional Information
Gregory P. Swanson, MD
The University of Texas Health Science Center at San Antonio Department of Radiation Oncology
Phone: 210-450-1109
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place