Trial Outcomes & Findings for A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors (NCT NCT01288989)
NCT ID: NCT01288989
Last Updated: 2019-06-17
Results Overview
AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
44 participants
Primary outcome timeframe
Baseline up to 46 months
Results posted on
2019-06-17
Participant Flow
Cohorts 1-4: Trial completion was defined as completion of the dose-limiting toxicity (DLT) period (4 weeks of IMC-3C5 followed by 2 weeks without drug) or IMC-3C5 discontinuation due to DLT. Cohort 5: Trial completion indicated that participants were fully observed for primary and secondary outcomes.
Participant milestones
| Measure |
5 mg/kg IMC-3C5
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
3
|
11
|
21
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
3
|
3
|
11
|
21
|
|
Overall Study
COMPLETED
|
5
|
3
|
3
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
6
|
Reasons for withdrawal
| Measure |
5 mg/kg IMC-3C5
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Dose limiting toxicity
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
5 mg/kg IMC-3C5
n=6 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=21 Participants
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.3 years
STANDARD_DEVIATION 14.92 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 10.43 • n=4 Participants
|
57.0 years
STANDARD_DEVIATION 12.07 • n=21 Participants
|
58.1 years
STANDARD_DEVIATION 11.90 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
44 Participants
n=8 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=8 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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
36 Participants
n=8 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=8 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=8 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 46 monthsPopulation: All participants who received at least one dose of study drug.
AEs include serious AEs (SAEs). AEs do not distinguish whether the events are treatment-emergent. A summary of serious and other non-serious AEs, regardless of causality, is presented in the Reported Adverse Event module.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=6 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=21 Participants
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
6 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 16 MonthsPopulation: All participants who received at least one dose of study drug. DLT was assessed in cohorts 1-4, only.
A DLT was defined as any adverse event (National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0) considered by the investigator to be definitely, probably, or possibly related to IMC-3C5, that occurred during the DLT Assessment Period (weeks 1 through 6) as follows: * Any Grade 3 or 4 hematologic toxicity * Any Grade 3 or 4 nonhematologic toxicity (excluding fatigue or anorexia lasting \<7 days, or Grade 3 nausea and/or vomiting that persisted for \<2 days following appropriate supportive care intervention)
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=6 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Dose-Limiting Toxicity (DLT)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline up to 46 MonthsPopulation: All participants who received at least one dose of study drug.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) and normalization of tumor marker level of non-target lesions; Partial Response (PR) was defined as having at least a 30% decrease in sum of longest diameter of target lesions. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir. Stable Disease (SD) was defined as small changes that did not meet above criteria.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=6 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=21 Participants
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)
Progressive disease
|
4 Participants
|
2 Participants
|
3 Participants
|
6 Participants
|
11 Participants
|
|
Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)
Stable disease
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)
Not evaluable
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. Prior to 1st infusion and 1 hour post infusion for cohort 5. (Cycle 1 = 4 - 6 weeks.)Population: All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=6 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=17 Participants
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of IMC-3C5 - First Infusion
|
110 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 21
|
259 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 26
|
435 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 15
|
689 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 18
|
711 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 27
|
SECONDARY outcome
Timeframe: Prior to 1st infusion (Day 1 of Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)Population: AUC 0-tlast was only measured in participants in cohorts 1-4, who received study drug and had sufficient evaluable AUC 0-tlast values.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=6 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=9 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion
|
9550 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 28
|
22400 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 24
|
37100 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 12
|
59900 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 30
|
—
|
SECONDARY outcome
Timeframe: Prior to 4th infusion (approximately Day 22, Cycle 1), immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. Prior to 4th infusion, 1 hour post infusion for cohort 5. (Cycle 1 = 4-6 weeks.)Population: All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=5 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=8 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=14 Participants
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion
|
198 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 13
|
456 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 22
|
754 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 17
|
1150 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 16
|
1130 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 23
|
SECONDARY outcome
Timeframe: Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)Population: AUCtau was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable AUCtau values.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=4 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=8 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion
|
20400 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 24
|
47300 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 28
|
81800 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 22
|
122000 microgram*hour/milliliter (µg*hr/mL)
Geometric Coefficient of Variation 18
|
—
|
SECONDARY outcome
Timeframe: Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)Population: t1/2 was estimated in participants in cohorts 1-4 who received study drug and had sufficient evaluable t1/2 values.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=3 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=1 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=6 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Terminal Half-life (t1/2) of IMC-3C5 - Fourth Infusion
|
11.7 days
Interval 10.4 to 13.7
|
8.45 days
n = 1.
|
8.97 days
Interval 8.81 to 9.22
|
10.4 days
Interval 8.79 to 12.1
|
—
|
SECONDARY outcome
Timeframe: Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)Population: Cohorts 1 - 3: Data not presented because extrapolated AUC was more than 30% and estimated Vss values may not be reliable. Cohort 4: All participants who received study drug and had sufficient evaluable Vss values.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=3 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Volume of Distribution of IMC-3C5 at Steady State (Vss) - Fourth Infusion
|
6.67 Liter (L)
Geometric Coefficient of Variation 8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to 4th infusion (approximately Day 22) of Cycle 1, immediately after, 0.5, 1, 2, 4, 8, 24, 48, 96, 168, 264, 336, 504 hours post infusion for cohorts 1-4. (Cycle 1 = 6 weeks.)Population: Cl was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable Cl values.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=4 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=8 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Clearance (Cl) of IMC-3C5 at Steady State - Fourth Infusion
|
0.0198 Liter/hour (L/h)
Geometric Coefficient of Variation 39
|
0.0192 Liter/hour (L/h)
Geometric Coefficient of Variation 29
|
0.0181 Liter/hour (L/h)
Geometric Coefficient of Variation 27
|
0.0191 Liter/hour (L/h)
Geometric Coefficient of Variation 19
|
—
|
SECONDARY outcome
Timeframe: Prior to 4th infusion (approximately Day 22) of Cycle 1 for cohorts 1-5. (Cycle 1 = 4 - 6 weeks.)Population: All participants who received study drug and had sufficient evaluable Ctrough values.
Trough concentration (Ctrough) prior to fourth infusion of Cycle 1.
Outcome measures
| Measure |
5 mg/kg IMC-3C5
n=4 Participants
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 Participants
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 Participants
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=8 Participants
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=16 Participants
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or other withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Minimum Concentration (Cmin) of IMC-3C5 - Fourth Infusion
|
72.4 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 37
|
175 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 37
|
246 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 20
|
430 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 25
|
416 microgram/milliliter (µg/mL)
Geometric Coefficient of Variation 30
|
SECONDARY outcome
Timeframe: Predose: First and fourth infusions (Cycle 1), ninth infusion (Cycle 3), 15th infusion (Cycle 4), 21st infusion (Cycle 6), 27th infusion (Cycle 7). (Cycle 1 = 4 - 6 weeks. Subsequent cycles = 4 weeks.)Population: Zero participants were analyzed. No assay was available to assess serum anti-IMC-3C5 antibodies.
Outcome measures
Outcome data not reported
Adverse Events
5 mg/kg IMC-3C5
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
10 mg/kg IMC-3C5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
20 mg/kg IMC-3C5
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg/kg IMC-3C5
Serious events: 5 serious events
Other events: 11 other events
Deaths: 0 deaths
30 mg/kg IMC-3C5 (CRC)
Serious events: 7 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
5 mg/kg IMC-3C5
n=6 participants at risk
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 participants at risk
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 participants at risk
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 participants at risk
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=21 participants at risk
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
18.2%
2/11 • Number of events 3
|
4.8%
1/21 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Immune system disorders
Anaphylactic reaction
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
Other adverse events
| Measure |
5 mg/kg IMC-3C5
n=6 participants at risk
Cohort 1: 5 milligrams/kilogram (mg/kg) IMC-3C5 administered intravenously (IV) once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
10 mg/kg IMC-3C5
n=3 participants at risk
Cohort 2: 10 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
20 mg/kg IMC-3C5
n=3 participants at risk
Cohort 3: 20 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
30 mg/kg IMC-3C5
n=11 participants at risk
Cohort 4: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle). First treatment cycle is followed by two-week rest period (no drug).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
30 mg/kg IMC-3C5 (CRC)
n=21 participants at risk
Cohort 5: 30 mg/kg IMC-3C5 administered IV once per week for four weeks (4 week treatment cycle) to participants with advanced or metastatic colorectal cancer (CRC).
After 1 cycle of treatment, participants with complete or partial response or stable disease were permitted to receive IMC-3C5 at the same dose and schedule until disease progression or another withdrawal criterion was met.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
18.2%
2/11 • Number of events 7
|
14.3%
3/21 • Number of events 4
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
27.3%
3/11 • Number of events 6
|
9.5%
2/21 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6
|
33.3%
1/3 • Number of events 2
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
27.3%
3/11 • Number of events 3
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
27.3%
3/11 • Number of events 7
|
9.5%
2/21 • Number of events 2
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Gastrointestinal disorders
Flatulence
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 2
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
66.7%
2/3 • Number of events 2
|
54.5%
6/11 • Number of events 10
|
42.9%
9/21 • Number of events 11
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
14.3%
3/21 • Number of events 3
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
45.5%
5/11 • Number of events 11
|
19.0%
4/21 • Number of events 6
|
|
General disorders
Chest discomfort
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
General disorders
Fatigue
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
36.4%
4/11 • Number of events 4
|
42.9%
9/21 • Number of events 16
|
|
General disorders
Injection site bruising
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
General disorders
Medical device pain
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 2
|
|
General disorders
Oedema
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 2
|
0.00%
0/21
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
19.0%
4/21 • Number of events 5
|
|
General disorders
Pain
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Pyrexia
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
45.5%
5/11 • Number of events 7
|
23.8%
5/21 • Number of events 6
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Infections and infestations
Candida infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
23.8%
5/21 • Number of events 6
|
|
Infections and infestations
Viral pharyngitis
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
Investigations
Blood calcium decreased
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 2
|
0.00%
0/21
|
|
Investigations
Haematocrit decreased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Investigations
Protein urine present
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
27.3%
3/11 • Number of events 3
|
33.3%
7/21 • Number of events 11
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
23.8%
5/21 • Number of events 9
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
14.3%
3/21 • Number of events 7
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
23.8%
5/21 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 2
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
19.0%
4/21 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 3
|
0.00%
0/21
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 4
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
14.3%
3/21 • Number of events 4
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
18.2%
2/11 • Number of events 2
|
0.00%
0/21
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Psychiatric disorders
Agitation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
19.0%
4/21 • Number of events 4
|
|
Psychiatric disorders
Confusional state
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Renal and urinary disorders
Micturition frequency decreased
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
0.00%
0/11
|
0.00%
0/21
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/1
|
0.00%
0/2
|
—
0/0
|
0.00%
0/6
|
11.1%
1/9 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
23.8%
5/21 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
4.8%
1/21 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
19.0%
4/21 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
9.5%
2/21 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6
|
0.00%
0/3
|
33.3%
1/3 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Papule
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
16.7%
1/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Vascular disorders
Flushing
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
0.00%
0/21
|
|
Vascular disorders
Hypertension
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
0.00%
0/11
|
14.3%
3/21 • Number of events 5
|
|
Vascular disorders
Hypotension
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/3
|
9.1%
1/11 • Number of events 1
|
4.8%
1/21 • 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
- Publication restrictions are in place
Restriction type: GT60