Trial Outcomes & Findings for A Study of IMC-A12 in Advanced Solid Tumors (NCT NCT01007032)
NCT ID: NCT01007032
Last Updated: 2019-02-27
Results Overview
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
21 participants
Primary outcome timeframe
Up To 63 Months
Results posted on
2019-02-27
Participant Flow
Participants who had progressive disease (PD) were considered to complete the study.
Participant milestones
| Measure |
Cixutumumab Cohort 1
6 milligrams/kilograms (mg/kg) of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
3
|
7
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
7
|
3
|
7
|
|
Overall Study
COMPLETED
|
4
|
6
|
2
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Cixutumumab Cohort 1
6 milligrams/kilograms (mg/kg) of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Overall Study
On Study Treatment at Cut-off Date
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of IMC-A12 in Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 9.52 • n=93 Participants
|
60.5 years
STANDARD_DEVIATION 6.82 • n=4 Participants
|
62.2 years
STANDARD_DEVIATION 5.57 • n=27 Participants
|
60.3 years
STANDARD_DEVIATION 8.67 • n=483 Participants
|
60.9 years
STANDARD_DEVIATION 7.33 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Japan
|
4 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
21 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Up To 63 MonthsPopulation: All participants who received at least 1 dose of study drug.
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Summary Listing of Percentage of Participants Reporting Treatment-Emergent Adverse Events
|
100 percentage of participants
|
85.7 percentage of participants
|
100 percentage of participants
|
85.7 percentage of participants
|
PRIMARY outcome
Timeframe: First Dose Up to 6 WeeksPopulation: All participants who completed the first cycle of 6 weeks or discontinued due to Dose Limiting Toxicities (DLTs).
DLTs were defined as any cixutumumab-related Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE 3.0) Grade 3 or 4 adverse events (reported in the subsequent Primary Outcome Measure).
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Number of Participants With a Dose Limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 Hours Following End of InfusionPopulation: All participants who received at least 1 dose of study drug and had evaluable PK data for Cmax (First Dose and Fourth doses for Cohorts 1 and 2 and First and Third doses for Cohorts 3 and 4.)
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=3 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=5 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax)
First Dose
|
184 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 34
|
643 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 95
|
1020 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 32
|
1390 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 22
|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax)
Fourth Dose or Third Dose
|
NA microgram/milliliter (μg/mL)
Geometric Coefficient of Variation NA
The geometric mean and % coefficient of variation (CV) were not calculated because there was 1 evaluable participant. Cmax=390.019 μg/mL
|
734 microgram/milliliter (μg/mL)
Geometric Coefficient of Variation 102
|
—
|
NA microgram/milliliter (μg/mL)
Geometric Coefficient of Variation NA
The geometric mean and % CV were not calculated because there was 1 participant in Cohort 4. Cmax=1741.312 μg/mL
|
PRIMARY outcome
Timeframe: Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 Hours Following End of InfusionPopulation: All participants who received at least 1 dose of study drug and had evaluable PK data for AUC(0-∞). First Dose for Cohorts 1, 2, 3, and 4.
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=4 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=2 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
PK: Area Under the Curve From Zero to Infinity AUC(0-∞)
|
26500 micrograms•hour/milliliter (μg•h/mL)
Geometric Coefficient of Variation 19
|
42000 micrograms•hour/milliliter (μg•h/mL)
Geometric Coefficient of Variation 50
|
120000 micrograms•hour/milliliter (μg•h/mL)
Geometric Coefficient of Variation 51
|
157000 micrograms•hour/milliliter (μg•h/mL)
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 Hours Following End of InfusionPopulation: All participants who received 1 dose of study drug and had evaluable PK data for (AUCtau). Fourth doses for Cohorts 1 and 2. No participant was evaluable in Cohorts 3 and 4.
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=2 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=3 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
PK: Area Under Concentration Versus Time Curve During One Dosing Interval (AUCtau)
|
36400 (μg•h/mL)
Geometric Coefficient of Variation 8
|
63600 (μg•h/mL)
Geometric Coefficient of Variation 40
|
—
|
—
|
PRIMARY outcome
Timeframe: Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 hours) Following End of InfusionPopulation: All participants who received at least 1 dose of study drug and had evaluable PK data for t1/2 estimation (First Dose and Fourth doses for Cohorts 1 and 2 and First Dose and Third doses for Cohorts 3 and 4.)
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Half-life (t1/2)
First Dose
|
6.08 day
Interval 5.29 to 6.88
|
4.06 day
Interval 3.33 to 6.04
|
9.88 day
Interval 6.58 to 16.0
|
8.83 day
Interval 4.67 to 13.8
|
|
Half-life (t1/2)
Fourth Dose or Third Dose (n=2,2,1,0)
|
NA day
The geometric mean and range were not calculated because there were 2 participants in Cohort 1. t1/2 values = 5.50; 4.75 days.
|
NA day
The geometric mean and range were not calculated because there were 2 participants in Cohort 2. t1/2 values = 4.29; 5.92 days.
|
NA day
The geometric mean and full range was not calculated due to 1 evaluable participant in Cohort 3. t1/2 value=6.96 days
|
—
|
PRIMARY outcome
Timeframe: Prior to Infusion and Immediately Following End of Infusion (Cohorts 1 and 2) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, and 336 hours and (Cohorts 3 and 4) at 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 408 and 504 hours) Following End of InfusionPopulation: All participants who received at least 1 dose of study drug and had evaluable PK data for CL estimation (First Dose and Fourth doses for Cohorts 1 and 2 and First Dose and Third doses for Cohorts 3 and 4.)
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Drug Clearance (CL)
First Dose
|
0.0137 Liter/hour (L/h)
Geometric Coefficient of Variation 13
|
0.0135 Liter/hour (L/h)
Geometric Coefficient of Variation 53
|
NA Liter/hour (L/h)
Geometric Coefficient of Variation NA
The geometric mean and CV were not calculated due to 2 participants in Cohort 3. Values=0.00574; 0.00948 L/h
|
0.00709 Liter/hour (L/h)
Geometric Coefficient of Variation 41
|
|
Drug Clearance (CL)
Fourth Dose or Third Dose (n=2,3,0,0)
|
NA Liter/hour (L/h)
Geometric Coefficient of Variation NA
The geometric mean and CV were not calculated due to 2 participants in Cohort 1. Values=0.0124; 0.0118 L/h
|
0.00994 Liter/hour (L/h)
Geometric Coefficient of Variation 49
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: No participants were analyzed due to no assay available.
No participants were analyzed for the development of circulating positive anti-cixutumumab antibodies due to no assay available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the First Dose up to 32 MonthsPopulation: All participants who received 1 dose of study drug.
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions.
Outcome measures
| Measure |
Cixutumumab Cohort 1
n=4 Participants
6 mg/kg of cixutumumab was administered intravenously (IV) every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 Participants
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 Participants
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 Participants
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
|
0.0 percentage of participants
Interval 0.0 to 60.2
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 16.1
|
Adverse Events
Cixutumumab Cohort 1
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cixutumumab Cohort 2
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Cixutumumab Cohort 3
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cixutumumab Cohort 4
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cixutumumab Cohort 1
n=4 participants at risk
6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 participants at risk
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 participants at risk
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 participants at risk
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Cixutumumab Cohort 1
n=4 participants at risk
6 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 2
n=7 participants at risk
10 mg/kg of cixutumumab was administered IV every 2 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 3
n=3 participants at risk
15 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
Cixutumumab Cohort 4
n=7 participants at risk
20 mg/kg of cixutumumab was administered IV every 3 weeks for 6 weeks (one cycle).
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Number of events 4
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus paralytic
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Number of events 6
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • Number of events 2
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 4
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Number of events 5
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Injection site extravasation
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
General disorders
Thirst
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood amylase increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Investigations
C-reactive protein increased
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
42.9%
3/7 • Number of events 3
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
57.1%
4/7 • Number of events 8
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 3
All participants who received at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 2
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 3
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/4
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
0.00%
0/3
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
28.6%
2/7 • Number of events 2
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1
All participants who received at least 1 dose of study drug.
|
14.3%
1/7 • Number of events 1
All participants who received at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1
All participants who received at least 1 dose of study drug.
|
0.00%
0/7
All participants who received at least 1 dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60