Trial Outcomes & Findings for An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma (NCT NCT01137006)
NCT ID: NCT01137006
Last Updated: 2019-06-17
Results Overview
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]
Results posted on
2019-06-17
Participant Flow
A completed participant (pt) finished the first 4 or 6 weeks of therapy or discontinued due to toxicity. Cohort (C)1A pts were treated sequentially. The next cohort started when all pts finished Cycle 1 of current cohort. Cohorts 1B-3B started if supported by C1A and C2A pharmacokinetic (PK) data and if maximum tolerated dose (MTD) not established.
Participant milestones
| Measure |
Cohort 1A (5 mg/kg, q2w)
IMC-20D7S: 5 milligrams per kilogram (mg/kg) IMC-20D7S administered intravenously (i.v.) as an infusion every other week (q2w) on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
|
Cohort 2A (10 mg/kg, q2w)
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion every three weeks (q3w) on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
8
|
3
|
3
|
4
|
3
|
|
Overall Study
Completed at Least 1 Treatment Cycle
|
3
|
3
|
8
|
3
|
3
|
4
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
8
|
3
|
3
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open-Label, Dose-Escalation Study of IMC-20D7S In Participants With Malignant Melanoma
Baseline characteristics by cohort
| Measure |
Cohort 1A (5 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
|
Cohort 2A (10 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
n=8 Participants
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
n=3 Participants
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
n=4 Participants
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
n=3 Participants
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
77.7 years
STANDARD_DEVIATION 5.50 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 4.92 • n=7 Participants
|
69.8 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
61.1 years
STANDARD_DEVIATION 11.70 • n=4 Participants
|
66.6 years
STANDARD_DEVIATION 4.41 • n=21 Participants
|
69.1 years
STANDARD_DEVIATION 5.53 • n=10 Participants
|
65.4 years
STANDARD_DEVIATION 18.90 • n=115 Participants
|
68.2 years
STANDARD_DEVIATION 9.26 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
11 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
16 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
26 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
25 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
4 participants
n=10 Participants
|
3 participants
n=115 Participants
|
27 participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline to toxicity [up to end of Cycle 1 (4 or 6-week cycles)]Population: Participants who completed Cycle 1 of treatment.
The MTD was defined as the dose preceding the dose level at which 2 participants experienced a dose-limiting toxicity (DLT) during treatment Cycle 1. A DLT was defined as any Grade 3 or above toxicity that emerged during study treatment and was clearly not attributable to malignant melanoma or co-medication and was possibly, probably, or definitely related to IMC-20D7S in the judgment of the investigator. No DLT was observed in the study; a provisional MTD was established.
Outcome measures
| Measure |
IMC-20D7S
n=27 Participants
IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle.
Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2A (10 mg/kg, q2w)
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of IMC-20D7S
|
20 mg/kg q2w
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline through 30 days post last dose (up to 31 weeks)Population: Participants who received any amount of IMC-20D7S .
A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
IMC-20D7S
n=3 Participants
IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle.
Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2A (10 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
n=8 Participants
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
n=3 Participants
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
n=4 Participants
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
n=3 Participants
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
SAEs
|
1 participants
|
1 participants
|
5 participants
|
2 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
Other Non-Serious AEs
|
3 participants
|
3 participants
|
8 participants
|
3 participants
|
2 participants
|
4 participants
|
3 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Other Non-Serious Adverse Events (AEs), or Death
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 hours (h) post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.Population: No participant was analyzed.
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.Population: No participant was analyzed.
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.Population: No participant was analyzed.
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.Population: No participant was analyzed.
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.Population: No participant was analyzed.
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycles 1 and 3: Prior to, immediately after, and 0.5, 1, 2, 4, 8, 24, 48 (Cycle 3 only), 96, 168, 240, and 336 h post first infusion. Cycles 2 and 4: Prior to and 1 h post first infusion.Population: No participant was analyzed.
A non-validated assay was used to determine individual serum concentrations of IMC-20D7S. Thus, analyses of PK data were not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Prior to the first and second infusion in each cycle up to Cycle 7 (4- and 6-week cycles)Population: No participant was analyzed.
Planned analyses for immunogenicity were not completed. A decision was made not to develop a validated immunogenicity assay because of the exploratory nature of the study and the analyses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose to disease progression or death (up to 27 weeks)Population: Participants who went beyond their first disease assessment and completed at least one treatment beyond Week 1 of treatment Cycle 3.
PFS was determined for participants who went beyond their first disease assessment and completed at least 1 treatment beyond Week 1 of treatment Cycle 3.
Outcome measures
| Measure |
IMC-20D7S
n=3 Participants
IMC-20D7S: Escalating doses (up to 30 mg/kg IMC-20D7S) administered i.v. as an infusion either q2w on Days 1 and 15 of each 4-week treatment cycle or q3w on Days 1 and 22 of each 6-week treatment cycle.
Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2A (10 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
n=8 Participants
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
n=3 Participants
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
n=3 Participants
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
n=4 Participants
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
n=3 Participants
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
0 participants
|
3 participants
|
2 participants
|
1 participants
|
1 participants
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Baseline to toxicity [up to end of Cycle 1 (4-or 6-week cycles)]Population: No participant was analyzed.
It was decided for administrative reasons to discontinue dosing at the provisional MTD rather than progress to Phase 1b.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1A (5 mg/kg, q2w)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2A (10 mg/kg, q2w)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3A (20 mg/kg, q2w)
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort 4A (30 mg/kg, q2w)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1B (10 mg/kg, q3w)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2B (20 mg/kg, q3w)
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3B (30 mg/kg, q3w)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1A (5 mg/kg, q2w)
n=3 participants at risk
IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
|
Cohort 2A (10 mg/kg, q2w)
n=3 participants at risk
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
n=8 participants at risk
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
n=3 participants at risk
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
n=3 participants at risk
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
n=4 participants at risk
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
n=3 participants at risk
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Disease progression
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
2/8 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Nervous system disorders
Syncope
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
Other adverse events
| Measure |
Cohort 1A (5 mg/kg, q2w)
n=3 participants at risk
IMC-20D7S: 5 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met. There were ≥7 days between the start of treatment for each participant in this cohort.
|
Cohort 2A (10 mg/kg, q2w)
n=3 participants at risk
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3A (20 mg/kg, q2w)
n=8 participants at risk
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 4A (30 mg/kg, q2w)
n=3 participants at risk
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q2w on Days 1 and 15 of each 4-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 1B (10 mg/kg, q3w)
n=3 participants at risk
IMC-20D7S: 10 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 2B (20 mg/kg, q3w)
n=4 participants at risk
IMC-20D7S: 20 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
Cohort 3B (30 mg/kg, q3w)
n=3 participants at risk
IMC-20D7S: 30 mg/kg IMC-20D7S administered i.v. as an infusion q3w on Days 1 and 22 of each 6-week treatment cycle until disease progression, unacceptable toxicity, or other withdrawal criteria were met.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Eye disorders
Eye pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Eye disorders
Eye swelling
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Breath odour
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
4/8 • Number of events 4
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
66.7%
2/3 • Number of events 3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Catheter site pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Chills
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Cyst
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
General disorders
Disease progression
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
50.0%
4/8 • Number of events 5
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
66.7%
2/3 • Number of events 3
|
|
General disorders
Feeling cold
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
General disorders
Influenza like illness
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Infusion related reaction
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
General disorders
Oedema peripheral
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Infections and infestations
Otitis externa
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Investigations
Weight increased
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 4
|
33.3%
1/3 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
66.7%
2/3 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
2/8 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Nodule on extremity
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 2
|
0.00%
0/3
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/5
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/1
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/1
|
0.00%
0/2
|
0.00%
0/5
|
50.0%
1/2 • Number of events 1
|
0.00%
0/2
|
0.00%
0/3
|
0.00%
0/1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
25.0%
2/8 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
33.3%
1/3 • Number of events 2
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Skin plaque
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/3
|
0.00%
0/3
|
12.5%
1/8 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
|
Vascular disorders
Flushing
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
33.3%
1/3 • Number of events 1
|
|
Vascular disorders
Haematoma
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/8
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/3
|
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