Trial Outcomes & Findings for IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT (NCT NCT01885897)
NCT ID: NCT01885897
Last Updated: 2020-08-12
Results Overview
The Dose Limiting Toxicity (DLT) is defined as (during first treatment cycle only): * any treatment-emergent grade 3 non-hematologic toxicity lasting more than 48 hours (refer to section 6.2.1.1 for full definition) * any treatment-emergent grade 4 or 5 non-hematologic toxicity of any duration * grade III or IV acute GVHD within 6 weeks after the first ALT-803 dose Maximum Tolerated Dose (MTD) is defined as the dose level where ≤ 1 out of 6 patients has DLT during the first treatment cycle
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
4 weeks
Results posted on
2020-08-12
Participant Flow
Participant milestones
| Measure |
ALT-803, IV, 1 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
4
|
3
|
8
|
9
|
|
Overall Study
COMPLETED
|
6
|
3
|
4
|
3
|
8
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IL-15 Super Agonist ALT-803 to Treat Relapse Of Hematologic Malignancy After Allogeneic SCT
Baseline characteristics by cohort
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 Participants
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 Participants
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
Total
n=33 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
22 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
31 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=10 Participants
|
2 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=10 Participants
|
1 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
31 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
3 participants
n=4 Participants
|
8 participants
n=21 Participants
|
9 participants
n=10 Participants
|
33 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe Dose Limiting Toxicity (DLT) is defined as (during first treatment cycle only): * any treatment-emergent grade 3 non-hematologic toxicity lasting more than 48 hours (refer to section 6.2.1.1 for full definition) * any treatment-emergent grade 4 or 5 non-hematologic toxicity of any duration * grade III or IV acute GVHD within 6 weeks after the first ALT-803 dose Maximum Tolerated Dose (MTD) is defined as the dose level where ≤ 1 out of 6 patients has DLT during the first treatment cycle
Outcome measures
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 Participants
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 Participants
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicity (DLT) Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe potential efficacy of ALT-803 in this patient population is measured by the responses based on bone marrow examination 1 and 3 months after the last dose of ALT-803. Response was defined as follows: for AML and myelodysplastic syndromes (MDS) using the International Working Group modified criteria, non-Hodgkin lymphoma, and multiple myeloma using the International Myeloma Working Group Uniform Response Criteria, and acute lymphoblastic leukemia using protocol-specified criteria.
Outcome measures
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 Participants
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 Participants
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Potential Efficacy of ALT 803
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeksTo evaluate the safety of the ALT-803 when administered on this schedule. Excessive toxicity is defined as having a grade 3-5 non-hematologic, non-relapse and non-infectious toxicity (except fevers alone) based on the NCI's CTCAE version 4.
Outcome measures
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 Participants
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 Participants
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Excessive Toxicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 Participants
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 Participants
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Incidence of Acute Graft Versus Host Disease
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 Participants
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 Participants
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 Participants
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Incidence of Chronic Graft Versus Host Disease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ALT-803, IV, 1 mcg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 3 deaths
ALT-803, IV, 3 mcg/kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
ALT-803, IV, 6 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 4 deaths
ALT-803, IV, 10 mcg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
ALT-803, SQ, 6 mcg/kg
Serious events: 6 serious events
Other events: 8 other events
Deaths: 8 deaths
ALT-803, SQ, 10 mcg/kg
Serious events: 6 serious events
Other events: 9 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 participants at risk
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 participants at risk
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Catheter related infection
|
16.7%
1/6 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 2 • Two years
|
55.6%
5/9 • Number of events 5 • Two years
|
|
General disorders
Fever
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Shingles
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
Other adverse events
| Measure |
ALT-803, IV, 1 mcg/kg
n=6 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 3 mcg/kg
n=3 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 6 mcg/kg
n=4 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, IV, 10 mcg/kg
n=3 participants at risk
Weekly dose of ALT-803 at assigned dose once a week for 4 weeks.
|
ALT-803, SQ, 6 mcg/kg
n=8 participants at risk
Weekly dose of ALT-803 at assigned dose subcutaneously, once a week for 4 weeks.
|
ALT-803, SQ, 10 mcg/kg
n=9 participants at risk
Weekly dose of ALT-803 at assigned dose , subcutaneously, once a week for 4 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
25.0%
1/4 • Number of events 2 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Number of events 1 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
33.3%
1/3 • Number of events 3 • Two years
|
25.0%
2/8 • Number of events 2 • Two years
|
66.7%
6/9 • Number of events 12 • Two years
|
|
Infections and infestations
Catheter related infection
|
16.7%
1/6 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Injury, poisoning and procedural complications
Biopsy site oozing
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 2 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 2 • Two years
|
25.0%
1/4 • Number of events 2 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
INR increased
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 2 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
25.0%
1/4 • Number of events 2 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 2 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 4 • Two years
|
44.4%
4/9 • Number of events 5 • Two years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 7 • Two years
|
0.00%
0/9 • Two years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
37.5%
3/8 • Number of events 4 • Two years
|
22.2%
2/9 • Number of events 2 • Two years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 4 • Two years
|
22.2%
2/9 • Number of events 2 • Two years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 2 • Two years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
Cardiac disorders
Atrial flutter
|
16.7%
1/6 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 2 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 4 • Two years
|
33.3%
3/9 • Number of events 4 • Two years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
33.3%
3/9 • Number of events 3 • Two years
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 3 • Two years
|
0.00%
0/9 • Two years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Gastrointestinal disorders
Dark stools - intermittent
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
16.7%
1/6 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
0.00%
0/9 • Two years
|
|
General disorders
Chills
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 3 • Two years
|
|
General disorders
Edema face
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
General disorders
Fatigue
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
25.0%
1/4 • Number of events 1 • Two years
|
0.00%
0/3 • Two years
|
37.5%
3/8 • Number of events 5 • Two years
|
22.2%
2/9 • Number of events 2 • Two years
|
|
General disorders
Fever
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
25.0%
2/8 • Number of events 2 • Two years
|
0.00%
0/9 • Two years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 1 • Two years
|
0.00%
0/9 • Two years
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
0.00%
0/3 • Two years
|
12.5%
1/8 • Number of events 2 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
|
General disorders
Pain
|
0.00%
0/6 • Two years
|
0.00%
0/3 • Two years
|
0.00%
0/4 • Two years
|
33.3%
1/3 • Number of events 1 • Two years
|
0.00%
0/8 • Two years
|
11.1%
1/9 • Number of events 1 • Two years
|
Additional Information
Dr. Jeffrey Miller
Masonic Cancer Center, University of Minnesota
Phone: 612-626-4024
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place