Trial Outcomes & Findings for IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread (NCT NCT01099631)
NCT ID: NCT01099631
Last Updated: 2020-07-20
Results Overview
Maximum tolerated dose will be determined by the number of patients with Dose limiting toxicity (DLT) at a given dose level. DLT is defined as treatment related: Sepsis (salmonella) syndrome, Grade 4 vomiting or diarrhea, Other grade 3 or greater toxicity. If \> or = 2 patients at a dose level has a DLT, this level will be declared the MTD.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
Up to 24 Weeks After Dose of Salmonella typhimurium
Results posted on
2020-07-20
Participant Flow
Participant milestones
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
Patients received Level 1 = 10\^5 dose of of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
Patients received Level 4 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9th - Level 5
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
3
|
3
|
4
|
|
Overall Study
COMPLETED
|
6
|
3
|
3
|
3
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread
Baseline characteristics by cohort
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 Participants
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=3 Participants
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=3 Participants
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=3 Participants
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9 th - Level 5
n=3 Participants
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=4 Participants
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
12 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
10 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
2 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
11 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
2 Participants
n=16 Participants
|
11 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
22 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
18 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
1 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Up to 24 Weeks After Dose of Salmonella typhimuriumMaximum tolerated dose will be determined by the number of patients with Dose limiting toxicity (DLT) at a given dose level. DLT is defined as treatment related: Sepsis (salmonella) syndrome, Grade 4 vomiting or diarrhea, Other grade 3 or greater toxicity. If \> or = 2 patients at a dose level has a DLT, this level will be declared the MTD.
Outcome measures
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 Participants
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=3 Participants
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=3 Participants
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=3 Participants
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9th - Level 5
n=3 Participants
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=4 Participants
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Events to Determine the Maximum Tolerated Dose (MTD) of Salmonella Typhimurium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 Weeks After Treatment with Salmonella TyphimuriumEvaluation is performed using Response Evaluation Criteria in Solid Tumors (RECIST). Each patient will be assigned one of the following categories: Complete response (CR) the disappearance of all target lesion; Partial response (PR) at least a 30% decrease; Progressive disease (PD) at least a 20% increase, or the appearance of one or more new lesions; Stable disease (SD) neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease; early death from malignant disease; unknown (insufficient evaluation to determine response status).
Outcome measures
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 Participants
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=3 Participants
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=3 Participants
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=3 Participants
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9th - Level 5
n=3 Participants
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=4 Participants
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Number of Participants With Complete Response to Treatment
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 5 Weeks After Dosing with Salmonella typhimuriumPopulation: One patient in 10 to the 6 th - Level 2 arm was not evaluable. One patient in 10 to the 7 th - Level 3 arm was not evaluable. Two patients in 10 to the 8 th - Level 4 arm were not evaluable. Two patients in 10 to the 9th - Level 5 arm were not evaluable. Two patients in 10 to the 10th - Level 6 arm were not evaluable.
Patients receiving doses of 10\^5 through 10\^10 Colony forming units of Salmonella typhimurium had their peripheral blood flow cytometry performed to identify the NK (Natural killer) cells population (CD8-, CD4-, CD49b+) prior to administration and at 5 weeks post administration. The flow cytometry data below was gathered by gating on the lymphocyte population of cells in the patient's blood, as determined by FSC vs. SSC. The mean percentage of NK cells in sample's lymphocyte population is given.
Outcome measures
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 Participants
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=2 Participants
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=2 Participants
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=1 Participants
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9th - Level 5
n=1 Participants
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=2 Participants
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Peripheral Blood NK Cells Count
Before administration
|
10.52 peripheral NK cells percentage
Standard Deviation 5.41
|
8.2 peripheral NK cells percentage
Standard Deviation 2.55
|
17.1 peripheral NK cells percentage
Standard Deviation 3.3
|
23.5 peripheral NK cells percentage
Standard Deviation 0
|
19.6 peripheral NK cells percentage
Standard Deviation 0
|
6.55 peripheral NK cells percentage
Standard Deviation 0.49
|
|
Peripheral Blood NK Cells Count
After administration
|
13.75 peripheral NK cells percentage
Standard Deviation 5.18
|
9.3 peripheral NK cells percentage
Standard Deviation 3.54
|
19.7 peripheral NK cells percentage
Standard Deviation 8.06
|
28.8 peripheral NK cells percentage
Standard Deviation 0
|
23.9 peripheral NK cells percentage
Standard Deviation 0
|
5.65 peripheral NK cells percentage
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline and 5 Weeks After Dosing with Salmonella typhimuriumPopulation: One patient in 10 to the 6 th - Level 2 arm was not evaluable. One patient in 10 to the 7 th - Level 3 arm was not evaluable. Two patients in 10 to the 8 th - Level 4 arm were not evaluable. Two patients in 10 to the 9th - Level 5 arm were not evaluable. Two patients in 10 to the 10th - Level 6 arm were not evaluable.
Patients receiving doses of 10\^5 through 10\^10 Colony forming units of Salmonella typhimurium had their peripheral blood flow cytometry performed to identify the NK (Natural killer) cells population (CD25+, FoxP3+) prior to administration and at 5 weeks post administration. The flow cytometry data below was gathered by gating on the lymphocyte population of cells in the patient's blood, as determined by FSC vs. SSC. The mean percentage of T cells in sample's lymphocyte population is given.
Outcome measures
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 Participants
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=2 Participants
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=2 Participants
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=1 Participants
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9th - Level 5
n=1 Participants
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=4 Participants
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Peripheral Blood T Cells Count
Before administration
|
51.77 percent peripheral blood T cells
Standard Deviation 20.04
|
50.25 percent peripheral blood T cells
Standard Deviation 8.70
|
63 percent peripheral blood T cells
Standard Deviation 2.82
|
56.3 percent peripheral blood T cells
Standard Deviation 0
|
50.1 percent peripheral blood T cells
Standard Deviation 0
|
70.6 percent peripheral blood T cells
Standard Deviation 7.35
|
|
Peripheral Blood T Cells Count
After administration
|
53.92 percent peripheral blood T cells
Standard Deviation 9.17
|
64.25 percent peripheral blood T cells
Standard Deviation 8.98
|
45.3 percent peripheral blood T cells
Standard Deviation 20.85
|
42.4 percent peripheral blood T cells
Standard Deviation 0
|
53.2 percent peripheral blood T cells
Standard Deviation 0
|
77.65 percent peripheral blood T cells
Standard Deviation 1.63
|
Adverse Events
Salmonella Typhimurium 10 to the 5 th - Level 1
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Salmonella Typhimurium 10 to the 6 th - Level 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Salmonella Typhimurium 10 to the 7 th - Level 3
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Salmonella Typhimurium 10 to the 8 th - Level 4
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Salmonella Typhimurium 10 to the 9 th - Level 5
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Salmonella Typhimurium 10 to the 10 th - Level 6
Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 participants at risk
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=3 participants at risk
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=3 participants at risk
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=3 participants at risk
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9 th - Level 5
n=3 participants at risk
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=4 participants at risk
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
New compression fractures
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
GI bleeding
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Creatinine increased
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Hepatobiliary disorders
hyperkalemia
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Urosepsis
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
Other adverse events
| Measure |
Salmonella Typhimurium 10 to the 5 th - Level 1
n=6 participants at risk
Patients received Level 1 = 10\^5th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 6 th - Level 2
n=3 participants at risk
Patients received Level 2 = 10\^6th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 7 th - Level 3
n=3 participants at risk
Patients received Level 3 = 10\^7th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 8 th - Level 4
n=3 participants at risk
Patients received Level 4 = 10\^8th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 9 th - Level 5
n=3 participants at risk
Patients received Level 5 = 10\^9th dose of Salmonella typhimurium
|
Salmonella Typhimurium 10 to the 10 th - Level 6
n=4 participants at risk
Patients received Level 6 = 10\^10th dose of Salmonella typhimurium
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 4 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Eye disorders
Eye disorders - Other, specify
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
General disorders
Edema limbs
|
33.3%
2/6 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
100.0%
3/3 • Number of events 3 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
75.0%
3/4 • Number of events 4 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
General disorders
Fever
|
50.0%
3/6 • Number of events 3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
66.7%
2/3 • Number of events 3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 2 • 6 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 3 • 6 months
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
33.3%
2/6 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/6 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
75.0%
3/4 • Number of events 3 • 6 months
|
|
Psychiatric disorders
Confusion
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
33.3%
2/6 • Number of events 3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/4 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/4 • 6 months
|
Additional Information
Daniel Saltzman
Masonic Cancer Center, University of Minnesota
Phone: 612 626 4214
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place