Trial Outcomes & Findings for HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma (NCT NCT02370160)
NCT ID: NCT02370160
Last Updated: 2020-01-13
Results Overview
Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness: * any Grade 5 adverse event * any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days * any Grade 3 thrombocytopenia with bleeding * any Grade 4 non-hematologic adverse event during DT2219 infusion * any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Day 1 - Day 29
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 60 µg/kg/Dose (Phase II)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
3
|
|
Overall Study
COMPLETED
|
6
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
1
|
Reasons for withdrawal
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 60 µg/kg/Dose (Phase II)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
4
|
1
|
Baseline Characteristics
HM2014-26 DT2219 for Relapsed or Refractory B-Lineage Leukemia or Lymphoma
Baseline characteristics by cohort
| Measure |
DT2219ARL
n=18 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
|
Age, Continuous
|
68.11 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 - Day 29Dose limiting toxicity (DLT) is defined as any of the following adverse events occurring from study day 1 through 7 days after the last dose of DT2219 of the 1st treatment cycle, and not clearly attributed to the primary malignancy or intercurrent illness: * any Grade 5 adverse event * any Grade 4 neutropenia or thrombocytopenia lasting more for than 7 days * any Grade 3 thrombocytopenia with bleeding * any Grade 4 non-hematologic adverse event during DT2219 infusion * any Grade 3 non-hematologic adverse event occurring after completion of DT2219 infusion
Outcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=9 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=6 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=3 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Phase I: Incidence of Any DLT Attributed to DT2219 in the First Cycle
|
1 events
|
3 events
|
0 events
|
PRIMARY outcome
Timeframe: Day 29Population: 12 Subjects treated on dose level 1: 4 achieved stable disease and 1 had partial response
Response is defined as complete response, partial response and stable disease. Complete response is defined as the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Stable disease is defined as cancer that is neither decreasing nor increasing in extent or severity.
Outcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=12 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Phase ll: Overall Disease Response
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29A Serious Adverse Event is defined as an adverse event that results in any of the following outcomes: * Death * A life-threatening adverse event * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect. * Important medical event
Outcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=9 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=6 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=3 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Incidence of Serious Adverse Events
|
2 events
|
2 events
|
1 events
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Only 2 participants achieved CR or PR
Duration of response was calculated as duration between on-study date and best response date for those patients who achieved complete remission (CR) or partial response (PR)
Outcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=2 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Phase II : Duration of Response
|
59.5 days
Interval 27.0 to 92.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=9 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=6 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=3 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Disease-free Survival
|
7 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=9 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=6 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=3 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Overall Survival
|
3 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=6 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=3 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=1 Participants
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Time to Relapse/Progression
|
27.3 days
Interval 18.0 to 36.0
|
42 days
Interval 28.0 to 65.0
|
30 days
Interval 30.0 to 30.0
|
Adverse Events
DT2219ARL 60 µg/kg/Dose (Phase I)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 3 deaths
DT2219 80 µg/kg/Dose (Phase I)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 4 deaths
DT2219 (Phase II)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=9 participants at risk
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=6 participants at risk
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=3 participants at risk
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
Other adverse events
| Measure |
DT2219ARL 60 µg/kg/Dose (Phase I)
n=9 participants at risk
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 80 µg/kg/Dose (Phase I)
n=6 participants at risk
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
DT2219 (Phase II)
n=3 participants at risk
A recombinant bispecific antibody-targeted toxin.
DT2219ARL: DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
9/9 • Number of events 21 • Day 50 or 30 Days after last dose
|
66.7%
4/6 • Number of events 12 • Day 50 or 30 Days after last dose
|
100.0%
3/3 • Number of events 3 • Day 50 or 30 Days after last dose
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 3 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 4 • Day 50 or 30 Days after last dose
|
|
Immune system disorders
Allergic reaction
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 5 • Day 50 or 30 Days after last dose
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
6/9 • Number of events 12 • Day 50 or 30 Days after last dose
|
50.0%
3/6 • Number of events 7 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 3 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
Aspartate aminotransferase increased
|
88.9%
8/9 • Number of events 15 • Day 50 or 30 Days after last dose
|
83.3%
5/6 • Number of events 13 • Day 50 or 30 Days after last dose
|
100.0%
3/3 • Number of events 4 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 3 • Day 50 or 30 Days after last dose
|
|
Eye disorders
Blurred vision
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
General disorders
Chills
|
33.3%
3/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 2 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 3 • Day 50 or 30 Days after last dose
|
|
Investigations
Creatinine increased
|
22.2%
2/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
General disorders
Edema limbs
|
22.2%
2/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
General disorders
Fatigue
|
55.6%
5/9 • Number of events 5 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 3 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 3 • Day 50 or 30 Days after last dose
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
General disorders
Fever
|
22.2%
2/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
11.1%
1/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypernatremia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Vascular disorders
Hypertension
|
22.2%
2/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 4 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
77.8%
7/9 • Number of events 10 • Day 50 or 30 Days after last dose
|
66.7%
4/6 • Number of events 6 • Day 50 or 30 Days after last dose
|
100.0%
3/3 • Number of events 6 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
44.4%
4/9 • Number of events 8 • Day 50 or 30 Days after last dose
|
50.0%
3/6 • Number of events 4 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 4 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
3/9 • Number of events 4 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
3/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
50.0%
3/6 • Number of events 5 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Vascular disorders
Hypotension
|
33.3%
3/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
INR increased
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
Lipase increased
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
General disorders
Localized edema
|
22.2%
2/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Infections and infestations
Lung infection
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 2 • Day 50 or 30 Days after last dose
|
|
Investigations
Lymphocyte count decreased
|
55.6%
5/9 • Number of events 13 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 2 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
Neutrophil count decreased
|
22.2%
2/9 • Number of events 4 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 6 • Day 50 or 30 Days after last dose
|
|
General disorders
Pain
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Nervous system disorders
Paresthesia
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Investigations
Platelet count decreased
|
66.7%
6/9 • Number of events 8 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 5 • Day 50 or 30 Days after last dose
|
66.7%
2/3 • Number of events 5 • Day 50 or 30 Days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
22.2%
2/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
22.2%
2/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Infections and infestations
Sepsis
|
22.2%
2/9 • Number of events 2 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Blood and lymphatic system disorders
Spleen disorder
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
16.7%
1/6 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Ear and labyrinth disorders
Tinnitus
|
11.1%
1/9 • Number of events 1 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
0.00%
0/3 • Day 50 or 30 Days after last dose
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 3 • Day 50 or 30 Days after last dose
|
|
Investigations
Weight gain
|
33.3%
3/9 • Number of events 3 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/9 • Day 50 or 30 Days after last dose
|
0.00%
0/6 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 1 • Day 50 or 30 Days after last dose
|
|
Investigations
White blood cell decreased
|
22.2%
2/9 • Number of events 4 • Day 50 or 30 Days after last dose
|
33.3%
2/6 • Number of events 4 • Day 50 or 30 Days after last dose
|
33.3%
1/3 • Number of events 7 • Day 50 or 30 Days after last dose
|
Additional Information
Dr. Veronika Bachanova
Masonic Cancer Center at University of Minnesota
Phone: 612-625-8287
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place