Trial Outcomes & Findings for Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients (NCT NCT03712371)
NCT ID: NCT03712371
Last Updated: 2025-06-10
Results Overview
The maximum tolerated dose is defined as the dose that produces no more than 1 dose-limiting toxicity (DLT)in 6 subjects. Per protocol a DLT is defined as Grade 3 or higher hypophosphatemia and/ or Grade 3 or higher of any of the following toxicities, that the investigator deems related to chitosan, that do not improve or resolve within 7 days of onset: flatulence, increased stool bulkiness, bloating, nausea, heartburn
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
112 days
Results posted on
2025-06-10
Participant Flow
Participant milestones
| Measure |
Dose Level 1
Chitosan 500mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 2
Chitosan 1000mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 3
Chitosan 1500mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 4
Chitosan 2000mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dose Level 1
Chitosan 500mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 2
Chitosan 1000mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 3
Chitosan 1500mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 4
Chitosan 2000mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Chitosan for Pharmacologic Manipulation of AGE Levels in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
Chitosan Dose Level 1
n=3 Participants
ChChitosan dosing 500mg orally twice daily for 85 days.
|
Chitosan Dose Level 2
n=3 Participants
Chitosan dosing 1000mg orally twice daily for 85 days.
|
Chitosan Dose Level 3
n=3 Participants
Chitosan dosing 1500mg orally twice daily for 85 days.
|
Chitosan Dose Level 4
n=3 Participants
Chitosan dosing 2000mg orally twice daily for 85 days.
|
Total
n=12 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
|
|
Age, Categorical
Between 18 and 65 years
|
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
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
75 years
n=7 Participants
|
73 years
n=5 Participants
|
69 years
n=4 Participants
|
69.5 years
n=21 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
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=21 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
|
|
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
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 112 daysThe maximum tolerated dose is defined as the dose that produces no more than 1 dose-limiting toxicity (DLT)in 6 subjects. Per protocol a DLT is defined as Grade 3 or higher hypophosphatemia and/ or Grade 3 or higher of any of the following toxicities, that the investigator deems related to chitosan, that do not improve or resolve within 7 days of onset: flatulence, increased stool bulkiness, bloating, nausea, heartburn
Outcome measures
| Measure |
Dose Level 1
n=3 Participants
Chitosan 500mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 2
n=3 Participants
Chitosan 1000mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 3
n=3 Participants
Chitosan 1500mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days.
|
Dose Level 4
n=3 Participants
Chitosan 2000mg twice daily for a 28-day DLT evaluation period, and for a total treatment duration of 85 days
|
|---|---|---|---|---|
|
Maximum Tolerated Dose as Assessed by Number of Participants Who Experienced a Dose Limiting Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 112 daysPopulation: No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
No participants were analyzed for this outcome, therefore no data was collected. Study was terminated.
Outcome measures
Outcome data not reported
Adverse Events
Chitosan Dose Level 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Chitosan Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Chitosan Dose Level 3
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Chitosan Dose Level 4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Chitosan Dose Level 1
n=3 participants at risk
Chitosan 500mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
Chitosan Dose Level 2
n=3 participants at risk
Chitosan 1000mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
Chitosan Dose Level 3
n=3 participants at risk
Chitosan 1500mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
Chitosan Dose Level 4
n=3 participants at risk
Chitosan 2000mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
Other adverse events
| Measure |
Chitosan Dose Level 1
n=3 participants at risk
Chitosan 500mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
Chitosan Dose Level 2
n=3 participants at risk
Chitosan 1000mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
Chitosan Dose Level 3
n=3 participants at risk
Chitosan 1500mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
Chitosan Dose Level 4
n=3 participants at risk
Chitosan 2000mg orally twice daily for a 28 day DLT period and for a total dosing regimen of 85 days.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
bloating
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Eye disorders
eye redness
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Eye disorders
blurred vision
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
fatigue
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
generalized discomfort
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Reproductive system and breast disorders
erectile dysfunction
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
diarrhea
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
indigestion
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Nervous system disorders
dizziness
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Nervous system disorders
lightheadedness
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Renal and urinary disorders
dysuria
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
dry mouth
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Psychiatric disorders
depression
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
constipation
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
66.7%
2/3 • Number of events 2 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Renal and urinary disorders
bladder neck contracture
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
hypersomnia
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
non-cardiac chest pain
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
headache
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Metabolism and nutrition disorders
weight gain
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Renal and urinary disorders
frequent urination
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
increased stool bulkiness
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Nervous system disorders
difficulty with balance
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
General disorders
cognitive slowness
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
decreased muscle mass
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Renal and urinary disorders
increased urinary incontinence
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Renal and urinary disorders
nocturia
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Musculoskeletal and connective tissue disorders
neuropathic pain - limbs
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
33.3%
1/3 • Number of events 1 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
0.00%
0/3 • 1 year, 5 months, 14 days
NCI CTCAE version 5.0
|
Additional Information
Alan Brisendine, CCRP, Manager, Sponsor-Investigator Support Unit
Medical University of South Carolina, Hollings Cancer Center, Clinical Trials
Phone: 843-792-9007
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place