Trial Outcomes & Findings for A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is Available (NCT NCT00785538)
NCT ID: NCT00785538
Last Updated: 2019-01-08
Results Overview
Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Enrollment to study completion up to 215 weeks
Results posted on
2019-01-08
Participant Flow
For participants enrolled under Protocol Versions 1.0 and 2.0, there was a 2-week pharmacokinetic (PK) period prior to Cycle 1.
After completion of the 10 milligrams/kilogram (mg/kg) cohort, PK data were obtained that established a recommended dose for Phase 2 studies. Enrollment and dose escalation beyond 15 mg/kg was stopped. Participants with progressive disease (PD) or death were considered to have completed the study.
Participant milestones
| Measure |
3 mg/kg
3 mg/kg IMC-A12 administered intravenously (I.V.) on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with stable disease (SD) could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
PK Period
STARTED
|
7
|
1
|
1
|
0
|
|
PK Period
COMPLETED
|
7
|
1
|
1
|
0
|
|
PK Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period
STARTED
|
7
|
9
|
6
|
2
|
|
Treatment Period
Received at Least 1 Dose of Study Drug
|
7
|
9
|
6
|
2
|
|
Treatment Period
COMPLETED
|
6
|
7
|
4
|
1
|
|
Treatment Period
NOT COMPLETED
|
1
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
3 mg/kg
3 mg/kg IMC-A12 administered intravenously (I.V.) on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with stable disease (SD) could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Treatment Period
Adverse Event
|
1
|
2
|
2
|
0
|
|
Treatment Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of IMC-A12 in Participants With Tumors Who No Longer Respond to Treatment or For Whom No Treatment is Available
Baseline characteristics by cohort
| Measure |
3 mg/kg
n=7 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=9 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=6 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=2 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65.7 years
FULL_RANGE 10.43 • n=5 Participants
|
56.4 years
FULL_RANGE 6.30 • n=7 Participants
|
59.4 years
FULL_RANGE 15.17 • n=5 Participants
|
42.9 years
FULL_RANGE 15.13 • n=4 Participants
|
57.2 years
FULL_RANGE 11.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
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/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Enrollment to study completion up to 215 weeksPopulation: All enrolled participants who received at least 1 dose of study drug.
Data presented are the number of participants who experienced serious adverse events (SAEs), other non-serious AEs and deaths during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
3 mg/kg
n=7 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=9 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=6 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=2 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) or Deaths
SAEs
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs) or Deaths
AEs
|
7 Participants
|
8 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs) or Deaths
Death due to PD
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: All participants who received at least 1 dose of study drug and completed Cycle 1 and 2-week observation or discontinued treatment for an IMC-A12-related toxicity.
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT). A DLT was defined as any Grade 3 or 4 hematologic or nonhematologic toxicity based on Common Terminology Criteria for AE (CTCAE), excluding alopecia, which was considered by the investigator to be definitely, probably, or possibly related to IMC-A12.
Outcome measures
| Measure |
3 mg/kg
n=6 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=7 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=5 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD)
|
NA mg/kg
MTD was not reached because \<2 participants experiencing a DLT.
|
NA mg/kg
MTD was not reached because \<2 participants experiencing a DLT.
|
NA mg/kg
MTD was not reached because \<2 participants experiencing a DLT.
|
NA mg/kg
MTD was not reached because of early stopping based on PK results.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1Population: All participants who received study drug and had PK data available to calculate Cmax.
Outcome measures
| Measure |
3 mg/kg
n=4 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=3 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=1 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax) of IMC-A12 Following Multiple Doses
|
292 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 42
|
385 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation 51
|
734 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
965 micrograms/milliliter (µg/mL)
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1Population: All participants who received study drug and had PK data available to calculate Cmin.
Outcome measures
| Measure |
3 mg/kg
n=3 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=2 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=1 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Observed Serum Concentration of IMC-A12 at 168 Hour Post End of Infusion Following Multiple Doses
|
74.8 µg/mL
Geometric Coefficient of Variation 28
|
154 µg/mL
Geometric Coefficient of Variation NA
2 participants were analyzed; therefore arithmetic mean was calculated and geometric coefficient of variation was not calculated.
|
226 µg/mL
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
122 µg/mL
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1Population: All participants who received study drug and had PK data available to calculate AUCτ.
Outcome measures
| Measure |
3 mg/kg
n=3 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=2 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=1 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve of IMC-A12 During One Dosing Interval (AUCτ) Following Multiple Doses
|
19800 micrograms*hour/milliliter (µg*h/mL
Geometric Coefficient of Variation 39
|
36350 micrograms*hour/milliliter (µg*h/mL
Geometric Coefficient of Variation NA
2 participants were analyzed; therefore arithmetic mean was calculated and geometric coefficient of variation was not calculated.
|
66700 micrograms*hour/milliliter (µg*h/mL
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
49300 micrograms*hour/milliliter (µg*h/mL
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1Population: All participants who received study drug and had PK data available to calculate t1/2. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
Half-Life (t1/2) is the time measured for the plasma concentration of the drug to decrease by one half. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
Outcome measures
| Measure |
3 mg/kg
n=2 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Half-Life (t1/2) of IMC-A12 Following Multiple Doses
|
6.19 days
Geometric Coefficient of Variation NA
2 participants were analyzed; therefore arithmetic mean was calculated and geometric coefficient of variation was not calculated.
|
—
|
—
|
6.17 days
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1Population: All participants who received study drug and had PK data available to calculate CLss.
CLss is the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time at steady-state.
Outcome measures
| Measure |
3 mg/kg
n=3 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=2 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=1 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Clearance Rate of IMC-A12 at Steady State (CLss) Following Multiple Doses
|
0.0124 Liters/hour (L/h)
Geometric Coefficient of Variation 40
|
0.0125 Liters/hour (L/h)
Geometric Coefficient of Variation NA
2 participants were analyzed; therefore arithmetic mean was calculated and geometric coefficient of variation was not calculated.
|
0.0114 Liters/hour (L/h)
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
0.0296 Liters/hour (L/h)
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264 and 336 hours after the infusion of Cycle 1Population: All participants who received study drug and had PK data available to calculate Vss. Zero participants were analyzed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug at steady-state. The analysis was not performed for the 6 mg/kg and 10 mg/kg dosing groups due to insufficient PK data.
Outcome measures
| Measure |
3 mg/kg
n=2 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=1 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Volume of Distribution of IMC-A12 at Steady State (Vss) Following Multiple Doses
|
2.88 Liters (L)
Geometric Coefficient of Variation NA
2 participants were analyzed; therefore arithmetic mean was calculated and geometric coefficient of variation was not calculated.
|
—
|
—
|
5.19 Liters (L)
Geometric Coefficient of Variation NA
1 participant was analyzed; therefore actual value was presented and geometric coefficient of variation was not calculated.
|
SECONDARY outcome
Timeframe: Before the last infusion of each treatment cyclePopulation: Zero participants were analyzed due to lack of available assay.
Analysis was not performed due to lack of available assay.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Enrollment to study completion up to 215 weeksPopulation: All enrolled participants.
Stable Disease (SD) is neither sufficient shrinkage to qualify for partial response (PR) nor sufficient increase to qualify for progressive disease (PD). PR and PD were assessed by investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PR is ≥30% decrease in sum of longest diameter of target lesions. PD is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion. Participants with a global deterioration of their health status requiring discontinuation of treatment without objective evidence of disease progression at that time were to be reported as "symptomatic deterioration"
Outcome measures
| Measure |
3 mg/kg
n=7 Participants
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=9 Participants
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=6 Participants
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=2 Participants
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Number of Participants With Best Overall Response
Stable Disease (SD)
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response
Progressive Disease (PD)
|
5 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Best Overall Response
Symptomatic Deterioration
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response
Not Evaluable
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Best Overall Response
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
3 mg/kg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
6 mg/kg
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
10 mg/kg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
15 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
3 mg/kg
n=7 participants at risk
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=9 participants at risk
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=6 participants at risk
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=2 participants at risk
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
NAUSEA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
VOMITING
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
General disorders
ASTHENIA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
DISEASE PROGRESSION
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
BACTERAEMIA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Infections and infestations
PNEUMONIA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
Other adverse events
| Measure |
3 mg/kg
n=7 participants at risk
3 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
3 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
6 mg/kg
n=9 participants at risk
6 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
6 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
10 mg/kg
n=6 participants at risk
10 mg/kg IMC-A12 administered I.V. on Day 1 of a 2-week PK period prior to Cycle 1.
10 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
15 mg/kg
n=2 participants at risk
15 mg/kg IMC-A12 administered I.V. once a week for 4 weeks, for a total of 4 doses per cycle. Cycle 1 was followed by a 2-week observation.
Participants with an objective response after Cycle 1 could have received additional treatment cycles at the same dose and schedule until disease progression or withdrawal criteria were met. Participants with SD could have received up to 2 additional 4-week treatment cycles at the same dose and schedule.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
ANAEMIA
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Eye disorders
VISUAL DISTURBANCE
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
28.6%
2/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
ASCITES
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
CONSTIPATION
|
14.3%
1/7 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
DIARRHOEA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
DYSPEPSIA
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 2
|
|
Gastrointestinal disorders
NAUSEA
|
14.3%
1/7 • Number of events 1
|
22.2%
2/9 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
100.0%
2/2 • Number of events 3
|
|
Gastrointestinal disorders
ORAL PAIN
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
RECTAL PROLAPSE
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
VOMITING
|
28.6%
2/7 • Number of events 2
|
22.2%
2/9 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
General disorders
ASTHENIA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
General disorders
CHILLS
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
General disorders
EARLY SATIETY
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
FATIGUE
|
28.6%
2/7 • Number of events 2
|
22.2%
2/9 • Number of events 3
|
83.3%
5/6 • Number of events 5
|
50.0%
1/2 • Number of events 2
|
|
General disorders
GAIT DISTURBANCE
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
INFUSION RELATED REACTION
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
General disorders
NODULE
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
General disorders
PAIN
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Infections and infestations
URINARY TRACT INFECTION
|
14.3%
1/7 • Number of events 3
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Injury, poisoning and procedural complications
INCISION SITE COMPLICATION
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Investigations
DENTAL EXAMINATION ABNORMAL
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Investigations
SPUTUM ABNORMAL
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Investigations
WEIGHT DECREASED
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
28.6%
2/7 • Number of events 2
|
0.00%
0/9
|
33.3%
2/6 • Number of events 3
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/7
|
22.2%
2/9 • Number of events 2
|
0.00%
0/6
|
50.0%
1/2 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
OSTEONECROSIS
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Musculoskeletal and connective tissue disorders
SHOULDER PAIN
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Nervous system disorders
DIZZINESS
|
14.3%
1/7 • Number of events 1
|
11.1%
1/9 • Number of events 2
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Nervous system disorders
HEADACHE
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
33.3%
2/6 • Number of events 2
|
0.00%
0/2
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Psychiatric disorders
INSOMNIA
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
MICTURITION URGENCY
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
NEPHROPATHY TOXIC
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.00%
0/4
|
0.00%
0/4
|
0.00%
0/5
|
100.0%
1/1 • Number of events 1
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
0.00%
0/3
|
0.00%
0/5
|
100.0%
1/1 • Number of events 1
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
BREATH SOUNDS DECREASED
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
CRACKLES LUNG
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
33.3%
2/6 • Number of events 2
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
POSTNASAL DRIP
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/7
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
14.3%
1/7 • Number of events 2
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
14.3%
1/7 • Number of events 1
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
RASH
|
28.6%
2/7 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
0.00%
0/6
|
0.00%
0/2
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/7
|
0.00%
0/9
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Vascular disorders
VARICOSE VEIN
|
0.00%
0/7
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
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