Trial Outcomes & Findings for Study of IMC-EB10 in Participant With Leukemia (NCT NCT00887926)
NCT ID: NCT00887926
Last Updated: 2022-12-22
Results Overview
MTD is defined as the dose preceding the dose level at which 2 participants experienced a dose limiting toxicity (DLT) during Cycle 1. DLT is defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0): (1) any Grade 3 or 4 toxicity that is clearly not attributable to leukemia \[for example (e.g.) a type of end-organ failure that is infrequently encountered in acute myeloid leukemia (AML)\] and is possibly, probably, or definitely attributable to IMC-EB10 in the judgment of the investigator; and (2) any Grade 3 or 4 toxicity that is clearly not attributable to a co-medication (e.g., prolonged neutropenia that is not attributable to hydroxyurea).
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Cycle 1 (28-day cycle)
Results posted on
2022-12-22
Participant Flow
Participant Flow is reporting enrolled participants who discontinued from the study. Participants who died or had progressive disease (PD) were considered to have completed the study.
Participant milestones
| Measure |
Cohort 1 - 5mg/kg IMC-EB10 (LY3012218)
IMC-EB10: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 2 - 10 mg/kg IMC-EB10
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
14
|
3
|
5
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
3
|
13
|
3
|
5
|
|
Overall Study
COMPLETED
|
3
|
13
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 - 5mg/kg IMC-EB10 (LY3012218)
IMC-EB10: 5 milligrams/kilogram (mg/kg) administered intravenously (IV) on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 2 - 10 mg/kg IMC-EB10
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of IMC-EB10 in Participant With Leukemia
Baseline characteristics by cohort
| Measure |
Cohort 1 - 5mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 2 - 10 mg/kg IMC-EB10
n=13 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=5 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.7 years
STANDARD_DEVIATION 5.97 • n=5 Participants
|
63.9 years
STANDARD_DEVIATION 18.52 • n=7 Participants
|
74.8 years
STANDARD_DEVIATION 4.45 • n=5 Participants
|
60.3 years
STANDARD_DEVIATION 16.91 • n=4 Participants
|
65.0 years
STANDARD_DEVIATION 15.89 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28-day cycle)Population: All participants who received at least 1 dose of study drug.
MTD is defined as the dose preceding the dose level at which 2 participants experienced a dose limiting toxicity (DLT) during Cycle 1. DLT is defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0): (1) any Grade 3 or 4 toxicity that is clearly not attributable to leukemia \[for example (e.g.) a type of end-organ failure that is infrequently encountered in acute myeloid leukemia (AML)\] and is possibly, probably, or definitely attributable to IMC-EB10 in the judgment of the investigator; and (2) any Grade 3 or 4 toxicity that is clearly not attributable to a co-medication (e.g., prolonged neutropenia that is not attributable to hydroxyurea).
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=24 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Maximum Tolerate Dose (MTD) of IMC-EB10
|
NA mg/kg
The MTD was below the level required for efficacy and the study was terminated early. Therefore, due to insufficient number of participants with events, 30 mg/kg was not fully expanded and the recommended MTD could not be calculated
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Week 1: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 96, and 168 h after infusion ends, and Cycle 1 Week 3: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycles)Population: All randomized participants with Cmax results.
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=3 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
n=11 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=4 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Pharmacokinetic (PK): Maximum Concentration (Cmax)
Week 3
|
119 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 24
|
781 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 66
|
1520 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 9
|
1770 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 74
|
|
Pharmacokinetic (PK): Maximum Concentration (Cmax)
Week 1
|
129 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 25
|
254 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 35
|
896 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 30
|
927 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Cycle 1 Week 1: predose, immediately after infusion, and at 1.5, 2, 4, 8, 24, 96 and 168 h after infusion ends (28-day cycle)Population: All randomized participants with AUC(0-last) results.
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=3 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
n=10 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Concentration [AUC(0-last)]
|
9090 micrograms * hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 39
|
23300 micrograms * hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 27
|
71800 micrograms * hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 40
|
77200 micrograms * hours/milliliter (µg*h/mL)
Geometric Coefficient of Variation 69
|
SECONDARY outcome
Timeframe: Cycle 1 Week 3: predose, immediately after infusion and at 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycle)Population: All randomized participants with AUCtau results.
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=2 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
n=5 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=2 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
PK: Area Under the Concentration Time Curve During the Dosing Interval (AUCtau) Where Tau is 168 Hours
|
NA µg*h/mL
Geometric Coefficient of Variation NA
The Geometric Mean and Geometric Coefficient of Variation was not estimated because of small number of participants with evaluable data (n=2). Individual participant data not provided for data privacy reasons.
|
72500 µg*h/mL
Geometric Coefficient of Variation 41
|
108000 µg*h/mL
Geometric Coefficient of Variation 39
|
NA µg*h/mL
Geometric Coefficient of Variation NA
The Geometric Mean and Geometric Coefficient of Variation was not estimated because of small number of participants with evaluable data (n=2). Individual participant data not provided for data privacy reasons.
|
SECONDARY outcome
Timeframe: 8 weeks and 30-day post-treatment follow-upPopulation: All randomized participants who received at least 1 dose of study drug.
Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=3 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
n=13 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=5 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) (Safety Profile of IMC-EB10)
SAEs
|
1 participants
|
7 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs) (Safety Profile of IMC-EB10)
Other Non-Serious AEs
|
3 participants
|
11 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Cycle 1, Weeks 1 and 3 and Cycle 2, Week 1: predose (28-day cycles)Population: Zero participants were analyzed. The study was discontinued early due to lack of efficacy and no data was collected.
A participant is considered positive for antibodies against IMC-EB10 if their blood sample exhibited a post-treatment antibody level that exceeds the positive upper cut point determined from the anti-IMC-EB10 level in healthy untreated individuals. A participant was considered to have an anti-IMC-EB10 response if there are 2 consecutive positive samples or if the final sample tested is positive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: All randomized participants who received at least 1 dose of study drug.No anti-leukemic responses were observed as there were no responders due to high rate of treatment failures and were not evaluable.
Assessment of antileukemic response was based on hematologic response criteria. PR defined as \>1000/microliter (µL) neutrophils and ≥100000/µL platelets in peripheral blood; a decrease of ≥50% in the pretreatment percentage of blasts to 5% to 25% in the bone marrow aspirate or a value of ≤5% blasts if Auer rods are present. Cytogenetic CR defined as normal cytogenetic findings. Molecular CR defined as negative findings for minimal residual disease by automated quantitative Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) and multidimensional flow cytometry. Morphologic CR with incomplete blood count recovery defined as ≤5% blasts (containing no Auer rods) in a bone marrow aspirate with spicules; neutrophil count \< 1000/µL or platelets \<100000/mL in peripheral blood or no extramedullary leukemia present.
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=3 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
n=13 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=5 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Number of Participants With Antileukemic Complete Response (CR) or Partial Response (PR)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 8Population: All randomized participants who received at least 1 dose of study drug. No tyrosine kinase responses were observed as there were no responders due to high rate of treatment failures and were not evaluable.
FLT3 response to IMC-EB10 is defined as wild type, internal tandem duplications (ITD) mutations and other mutations.
Outcome measures
| Measure |
IMC-EB10 5 to 30 mg/kg
n=3 Participants
Participants received either 5, 10, 20 or 30 mg/kg of IMC-EB10 IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle).
|
Cohort 2 - 10 mg/kg IMC-EB10
n=13 Participants
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 Participants
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=5 Participants
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Number of Participants With Feline McDonough Sarcoma (FMS)-Like Tyrosine Kinase 3 (FLT3) Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Cohort 1 - 5mg/kg IMC-EB10
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 - 10 mg/kg IMC-EB10
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 3 - 20 mg/kg IMC-EB10
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 - 30 mg/kg IMC-EB10
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 - 5mg/kg IMC-EB10
n=3 participants at risk
IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 2 - 10 mg/kg IMC-EB10
n=13 participants at risk
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 participants at risk
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=5 participants at risk
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Disease progression
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/3
|
0.00%
0/13
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1
|
38.5%
5/13 • Number of events 5
|
0.00%
0/3
|
0.00%
0/5
|
|
Infections and infestations
Sepsis
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
Other adverse events
| Measure |
Cohort 1 - 5mg/kg IMC-EB10
n=3 participants at risk
IMC-EB10: 5 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 2 - 10 mg/kg IMC-EB10
n=13 participants at risk
IMC-EB10: 10 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 3 - 20 mg/kg IMC-EB10
n=3 participants at risk
IMC-EB10: 20 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
Cohort 4 - 30 mg/kg IMC-EB10
n=5 participants at risk
IMC-EB10: 30 mg/kg administered IV on Days 1, 8, and 15 of Cycle 1 (28-day cycle) and Days 1, 8, 15, and 22 of subsequent 28-day cycles.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
46.2%
6/13 • Number of events 7
|
33.3%
1/3 • Number of events 1
|
40.0%
2/5 • Number of events 3
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3
|
0.00%
0/13
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
15.4%
2/13 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Cardiac disorders
Atrial fibrillation
|
66.7%
2/3 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Cardiac disorders
Atrial flutter
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Cardiac disorders
Bradycardia
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Eye disorders
Conjunctival pallor
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Eye disorders
Vision blurred
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Haemorrhoids
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
30.8%
4/13 • Number of events 4
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Chills
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
|
30.8%
4/13 • Number of events 4
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Generalised oedema
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
General disorders
Mucosal inflammation
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Multi-organ failure
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
General disorders
Pyrexia
|
66.7%
2/3 • Number of events 2
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Candidiasis
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Infections and infestations
Septic shock
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3
|
0.00%
0/13
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3
|
0.00%
0/13
|
33.3%
1/3 • Number of events 1
|
20.0%
1/5 • Number of events 1
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Investigations
Cardiac murmur
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Investigations
Weight decreased
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
23.1%
3/13 • Number of events 3
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
1/3 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
7.7%
1/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3
|
0.00%
0/13
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3
|
15.4%
2/13 • Number of events 2
|
0.00%
0/3
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
20.0%
1/5 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Vascular disorders
Deep vein thrombosis
|
33.3%
1/3 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/5
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1
|
30.8%
4/13 • Number of events 4
|
0.00%
0/3
|
0.00%
0/5
|
|
Vascular disorders
Pallor
|
0.00%
0/3
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/5
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER