Trial Outcomes & Findings for Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer (NCT NCT02555397)
NCT ID: NCT02555397
Last Updated: 2024-10-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
15 participants
Primary outcome timeframe
30 days from date of adenovirus injection (defined as day 1)
Results posted on
2024-10-10
Participant Flow
Participants were recruited based on physician referral from the department of Radiation Oncology and the department of Urology at the Henry Ford Cancer Institute, Henry Ford Health System
Participant milestones
| Measure |
AdV Dose: 1X10e10 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 viral particles.
|
AdV Dose: 3x10e10 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3 x 10e10 viral particles.
|
AdV Dose: 1x10e11 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e11 viral particles.
|
AdV Dose: 3x10e11 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3x10e11 viral particles.
|
AdV Dose: 1x10e12 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e12 viral particles.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
AdV Dose: 1X10e10 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 viral particles.
|
AdV Dose: 3x10e10 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3 x 10e10 viral particles.
|
AdV Dose: 1x10e11 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e11 viral particles.
|
AdV Dose: 3x10e11 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3x10e11 viral particles.
|
AdV Dose: 1x10e12 vp
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e12 viral particles.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 1 Trial of Interleukin 12 Gene Therapy for Locally Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
AdV Dose: 1X10e10 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 viral particles.
|
AdV Dose: 3x10e10 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3 x 10e10 viral particles.
|
AdV Dose: 1x10e11 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e11 viral particles.
|
AdV Dose: 3x10e11 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3x10e11 viral particles.
|
AdV Dose: 1x10e12 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e12 viral particles.
|
Total
n=15 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Tumor Stage
T1c
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Gleason Score
8
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
4 participants
n=8 Participants
|
|
Gleason Score
9
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=8 Participants
|
|
Gleason Score
10
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Gleason Score
Not assessed
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=8 Participants
|
|
Pre-T PSA (ng/ml)
<4 ng/mL
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Pre-T PSA (ng/ml)
>=4 and <10 ng/mL
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Pre-T PSA (ng/ml)
>=10 ng/mL
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Tumor Stage
T2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Tumor Stage
Not Detected
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Gleason Score
6
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
1 participants
n=8 Participants
|
|
Gleason Score
7
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
4 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 30 days from date of adenovirus injection (defined as day 1)Population: Arm specific adverse events
Outcome measures
| Measure |
AdV Dose: 1X10e10 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 viral particles.
|
AdV Dose: 3x10e10 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3 x 10e10 viral particles.
|
AdV Dose: 1x10e11 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e11 viral particles.
|
AdV Dose: 3x10e11 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3x10e11 viral particles
|
AdV Dose: 1x10e12 vp
n=3 Participants
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e12 viral particles.
|
|---|---|---|---|---|---|
|
Dose-dependent Toxicity
Urinary incontinence
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Urinary retention
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Thrombocytopenia
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Dose-dependent Toxicity
ALT/SGPT increased
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Dose-dependent Toxicity
AST/SGOT increased
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Dose-dependent Toxicity
Chills
|
0 participants
|
2 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Dose-dependent Toxicity
Cytokine release syndrome
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Mental status change
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Dose-dependent Toxicity
Dehydration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Dose-dependent Toxicity
Diarrhea
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Dose-dependent Toxicity
Dyspnea
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Dose-dependent Toxicity
Fatigue
|
2 participants
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Dose-dependent Toxicity
Fever
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Dose-dependent Toxicity
Flu-like symptoms
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Dose-dependent Toxicity
Hypotension
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Nausea
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Dose-dependent Toxicity
Urinary frequency
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Dose-dependent Toxicity
Urinary tract pain
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Vomiting
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Dose-dependent Toxicity
Malaise
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Dose-dependent Toxicity
Pain (thigh, kidney, head, fingers)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
|
Dose-dependent Toxicity
Anemia
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Dose-dependent Toxicity
Leukopenia
|
0 participants
|
2 participants
|
2 participants
|
1 participants
|
3 participants
|
|
Dose-dependent Toxicity
Lymphopenia
|
3 participants
|
1 participants
|
2 participants
|
2 participants
|
3 participants
|
|
Dose-dependent Toxicity
Neutropenia
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Dose-dependent Toxicity
ALKP increased
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
CPK increased
|
1 participants
|
1 participants
|
2 participants
|
3 participants
|
1 participants
|
|
Dose-dependent Toxicity
Creatinine increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Dose-dependent Toxicity
GGT increased
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Hypercalcemia
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Dose-dependent Toxicity
Hyperglycemia
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
2 participants
|
|
Dose-dependent Toxicity
Hypomagnesemia
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Dose-dependent Toxicity
Hyponatremia
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsOutcome measures
Outcome data not reported
Adverse Events
AdV Dose: 1X10e10 vp
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AdV Dose: 3x10e10 vp
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AdV Dose: 1x10e11 vp
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
AdV Dose: 3x10e11 vp
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
AdV Dose: 1x10e12 vp
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AdV Dose: 1X10e10 vp
n=3 participants at risk
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1 x 10e10 viral particles.
|
AdV Dose: 3x10e10 vp
n=3 participants at risk
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3 x 10e10 viral particles.
|
AdV Dose: 1x10e11 vp
n=3 participants at risk
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e11 viral particles.
|
AdV Dose: 3x10e11 vp
n=3 participants at risk
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 3x10e11 viral particles.
|
AdV Dose: 1x10e12 vp
n=3 participants at risk
Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 adenovirus at a dose of 1x10e12 viral particles.
|
|---|---|---|---|---|---|
|
General disorders
Dehydration
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Fever
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Nausea
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Cytokine release syndrome
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Mental Status Change
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Hypotension
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Renal and urinary disorders
Urinary Tract Pain
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 6 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
3/3 • Number of events 5 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 7 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
ALT/SGPT increased
|
33.3%
1/3 • Number of events 6 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
AST/SGOT increased
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
ALKP increased
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
CPK increased
|
33.3%
1/3 • Number of events 6 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 10 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 7 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Hypercalcemia
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Hyponatremia
|
33.3%
1/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • Number of events 6 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Pain (thigh, kidney, head, fingers)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Malaise
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Creatinine increase
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 5 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Blood and lymphatic system disorders
GGT Increase
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
Renal and urinary disorders
Urinary Frequency
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Diarrhea
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 4 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Chills
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
66.7%
2/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
100.0%
3/3 • Number of events 3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
|
General disorders
Flu-Like Symptoms
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
0.00%
0/3 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 1 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
33.3%
1/3 • Number of events 2 • All adverse events were collected through the primary toxicity endpoint (day 30)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place