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A Study of Anti-VEGFR-3 Monoclonal Antibody IMC-3C5 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01288989
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Neoplasms
Intervention Biological: IMC-3C5
Enrollment 44
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Hide Arm/Group Description

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 6 3 3 11 21
Received at Least 1 Dose of Study Drug 6 3 3 11 21
Completed 5 3 3 10 15
Not Completed 1 0 0 1 6
Reason Not Completed
Death             0             0             0             1             0
Dose limiting toxicity             1             0             0             0             0
Adverse Event             0             0             0             0             2
Physician Decision             0             0             0             0             1
Withdrawal by Subject             0             0             0             0             3
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC) Total
Hide Arm/Group Description

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.

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 6 3 3 11 21 44
Hide Baseline Analysis Population Description
All participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 3 participants 11 participants 21 participants 44 participants
61.3  (14.92) 59.0  (13.08) 67.0  (10.82) 55.7  (10.43) 57.0  (12.07) 58.1  (11.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 11 participants 21 participants 44 participants
Female
1
  16.7%
2
  66.7%
0
   0.0%
6
  54.5%
9
  42.9%
18
  40.9%
Male
5
  83.3%
1
  33.3%
3
 100.0%
5
  45.5%
12
  57.1%
26
  59.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 11 participants 21 participants 44 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
3
 100.0%
3
 100.0%
11
 100.0%
21
 100.0%
44
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 11 participants 21 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
3
  14.3%
4
   9.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
   9.1%
3
  14.3%
4
   9.1%
White
6
 100.0%
3
 100.0%
2
  66.7%
10
  90.9%
15
  71.4%
36
  81.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 3 participants 3 participants 11 participants 21 participants 44 participants
6
 100.0%
3
 100.0%
3
 100.0%
11
 100.0%
21
 100.0%
44
 100.0%
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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.
Time Frame Baseline up to 46 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Hide Arm/Group Description:

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.

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.

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.

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.

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 Number of Participants Analyzed 6 3 3 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
6 3 3 11 20
2.Primary Outcome
Title Number of Participants Reporting Dose-Limiting Toxicity (DLT)
Hide Description

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)
Time Frame Baseline up to 16 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug. DLT was assessed in cohorts 1-4, only.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 6 3 3 11
Measure Type: Count of Participants
Unit of Measure: Participants
1 0 0 0
3.Secondary Outcome
Title Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR)
Hide Description 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.
Time Frame Baseline up to 46 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Hide Arm/Group Description:

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.

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.

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.

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.

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 Number of Participants Analyzed 6 3 3 11 21
Measure Type: Count of Participants
Unit of Measure: Participants
Stable disease 1 1 0 2 4
Progressive disease 4 2 3 6 11
Not evaluable 1 0 0 3 6
4.Secondary Outcome
Title Maximum Concentration (Cmax) of IMC-3C5 - First Infusion
Hide Description [Not Specified]
Time Frame 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.)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Hide Arm/Group Description:

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.

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.

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.

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.

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 Number of Participants Analyzed 6 3 3 11 17
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (µg/mL)
110
(21%)
259
(26%)
435
(15%)
689
(18%)
711
(27%)
5.Secondary Outcome
Title Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion
Hide Description [Not Specified]
Time Frame 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.)
Hide Outcome Measure Data
Hide Analysis Population Description
AUC 0-tlast was only measured in participants in cohorts 1-4, who received study drug and had sufficient evaluable AUC 0-tlast values.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 6 3 3 9
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour/milliliter (µg*hr/mL)
9550
(28%)
22400
(24%)
37100
(12%)
59900
(30%)
6.Secondary Outcome
Title Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion
Hide Description [Not Specified]
Time Frame 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.)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Hide Arm/Group Description:

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.

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.

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.

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.

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 Number of Participants Analyzed 5 3 3 8 14
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (µg/mL)
198
(13%)
456
(22%)
754
(17%)
1150
(16%)
1130
(23%)
7.Secondary Outcome
Title Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion
Hide Description [Not Specified]
Time Frame 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.)
Hide Outcome Measure Data
Hide Analysis Population Description
AUCtau was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable AUCtau values.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 4 3 3 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram*hour/milliliter (µg*hr/mL)
20400
(24%)
47300
(28%)
81800
(22%)
122000
(18%)
8.Secondary Outcome
Title Terminal Half-life (t1/2) of IMC-3C5 - Fourth Infusion
Hide Description [Not Specified]
Time Frame 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.)
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Hide Analysis Population Description
t1/2 was estimated in participants in cohorts 1-4 who received study drug and had sufficient evaluable t1/2 values.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5
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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.

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.

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.

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.

Overall Number of Participants Analyzed 3 1 3 6
Geometric Mean (Full Range)
Unit of Measure: days
11.7
(10.4 to 13.7)
8.45 [1] 
(NA to NA)
8.97
(8.81 to 9.22)
10.4
(8.79 to 12.1)
[1]
n = 1.
9.Secondary Outcome
Title Volume of Distribution of IMC-3C5 at Steady State (Vss) - Fourth Infusion
Hide Description [Not Specified]
Time Frame 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.)
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Hide Analysis Population Description
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.
Arm/Group Title 30 mg/kg IMC-3C5
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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.

Overall Number of Participants Analyzed 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter (L)
6.67
(8%)
10.Secondary Outcome
Title Clearance (Cl) of IMC-3C5 at Steady State - Fourth Infusion
Hide Description [Not Specified]
Time Frame 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.)
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Hide Analysis Population Description
Cl was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable Cl values.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5
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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.

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.

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.

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.

Overall Number of Participants Analyzed 4 3 3 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Liter/hour (L/h)
0.0198
(39%)
0.0192
(29%)
0.0181
(27%)
0.0191
(19%)
11.Secondary Outcome
Title Minimum Concentration (Cmin) of IMC-3C5 - Fourth Infusion
Hide Description Trough concentration (Ctrough) prior to fourth infusion of Cycle 1.
Time Frame Prior to 4th infusion (approximately Day 22) of Cycle 1 for cohorts 1-5. (Cycle 1 = 4 - 6 weeks.)
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Hide Analysis Population Description
All participants who received study drug and had sufficient evaluable Ctrough values.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
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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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 4 3 3 8 16
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram/milliliter (µg/mL)
72.4
(37%)
175
(37%)
246
(20%)
430
(25%)
416
(30%)
12.Secondary Outcome
Title Anti-IMC-3C5 Antibody Assessment
Hide Description [Not Specified]
Time Frame 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.)
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Hide Analysis Population Description
Zero participants were analyzed. No assay was available to assess serum anti-IMC-3C5 antibodies.
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Hide Arm/Group Description:

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
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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.

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.

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.

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.

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.

All-Cause Mortality
5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      1/3 (33.33%)      1/3 (33.33%)      5/11 (45.45%)      7/21 (33.33%)    
Gastrointestinal disorders           
Constipation  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Small intestinal obstruction  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/11 (18.18%)  3 1/21 (4.76%)  1
Hepatobiliary disorders           
Bile duct stenosis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Hyperbilirubinaemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Immune system disorders           
Anaphylactic reaction  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Infections and infestations           
Clostridium difficile colitis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Pneumonia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Urinary tract infection  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Injury, poisoning and procedural complications           
Infusion related reaction  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders           
Hypomagnesaemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Nervous system disorders           
Cognitive disorder  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Nerve root compression  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders           
Renal failure  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Renal haemorrhage  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Respiratory, thoracic and mediastinal disorders           
Dyspnoea  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Hypoxia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Pulmonary embolism  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders           
Deep vein thrombosis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5 mg/kg IMC-3C5 10 mg/kg IMC-3C5 20 mg/kg IMC-3C5 30 mg/kg IMC-3C5 30 mg/kg IMC-3C5 (CRC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      11/11 (100.00%)      20/21 (95.24%)    
Blood and lymphatic system disorders           
Anaemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/11 (18.18%)  7 3/21 (14.29%)  4
Neutropenia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Thrombocytopenia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Cardiac disorders           
Sinus tachycardia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  2
Gastrointestinal disorders           
Abdominal distension  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 3/21 (14.29%)  3
Abdominal pain  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 3/11 (27.27%)  6 2/21 (9.52%)  3
Abdominal pain lower  1  0/6 (0.00%)  0 1/3 (33.33%)  2 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Abdominal pain upper  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Ascites  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Colitis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Constipation  1  1/6 (16.67%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 3/11 (27.27%)  3 2/21 (9.52%)  2
Diarrhoea  1  1/6 (16.67%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 1/11 (9.09%)  1 3/21 (14.29%)  3
Dyspepsia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/11 (27.27%)  7 2/21 (9.52%)  2
Dysphagia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Flatulence  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Gastrooesophageal reflux disease  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  2
Haematochezia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Nausea  1  1/6 (16.67%)  1 0/3 (0.00%)  0 2/3 (66.67%)  2 6/11 (54.55%)  10 9/21 (42.86%)  11
Rectal haemorrhage  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 3/21 (14.29%)  3
Small intestinal haemorrhage  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Vomiting  1  1/6 (16.67%)  3 1/3 (33.33%)  1 2/3 (66.67%)  2 5/11 (45.45%)  11 4/21 (19.05%)  6
General disorders           
Chest discomfort  1  1/6 (16.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Fatigue  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 4/11 (36.36%)  4 9/21 (42.86%)  16
Injection site bruising  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Medical device pain  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Non-cardiac chest pain  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  2
Oedema  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  2 0/21 (0.00%)  0
Oedema peripheral  1  1/6 (16.67%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 3/11 (27.27%)  3 4/21 (19.05%)  5
Pain  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  2
Pyrexia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 5/11 (45.45%)  7 5/21 (23.81%)  6
Immune system disorders           
Cytokine release syndrome  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Infections and infestations           
Candida infection  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Pneumonia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Urinary tract infection  1  0/6 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 2/11 (18.18%)  2 5/21 (23.81%)  6
Viral pharyngitis  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Injury, poisoning and procedural complications           
Fall  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Infusion related reaction  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  2
Investigations           
Alanine aminotransferase increased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Aspartate aminotransferase increased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Blood albumin decreased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Blood alkaline phosphatase increased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/11 (9.09%)  1 2/21 (9.52%)  2
Blood calcium decreased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Blood creatinine increased  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  2 0/21 (0.00%)  0
Haematocrit decreased  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Platelet count decreased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Protein urine present  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Metabolism and nutrition disorders           
Decreased appetite  1  2/6 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 3/11 (27.27%)  3 7/21 (33.33%)  11
Hyperglycaemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Hypoalbuminaemia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 5/21 (23.81%)  9
Hypokalaemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  2 1/21 (4.76%)  1
Hypomagnesaemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 3/21 (14.29%)  7
Hyponatraemia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 5/21 (23.81%)  9
Musculoskeletal and connective tissue disorders           
Arthralgia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  2 1/21 (4.76%)  1
Back pain  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/11 (9.09%)  1 4/21 (19.05%)  5
Bone pain  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Flank pain  1  1/6 (16.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Muscle spasms  1  1/6 (16.67%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Muscular weakness  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  4
Musculoskeletal pain  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  2
Myalgia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Pain in extremity  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/11 (9.09%)  3 0/21 (0.00%)  0
Pain in jaw  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Nervous system disorders           
Dizziness  1  2/6 (33.33%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  4
Dysgeusia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Headache  1  0/6 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 1/11 (9.09%)  1 3/21 (14.29%)  4
Hypoaesthesia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/11 (18.18%)  2 0/21 (0.00%)  0
Memory impairment  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Nerve root compression  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Neuralgia  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Peripheral sensory neuropathy  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  2
Somnolence  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Psychiatric disorders           
Agitation  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Anxiety  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 4/21 (19.05%)  4
Confusional state  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Insomnia  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Renal and urinary disorders           
Dysuria  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Micturition frequency decreased  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Pollakiuria  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Proteinuria  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Urinary retention  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/11 (0.00%)  0 0/21 (0.00%)  0
Reproductive system and breast disorders           
Vaginal haemorrhage  1  0/1 (0.00%)  0 0/2 (0.00%)  0 0/0  0 0/6 (0.00%)  0 1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders           
Cough  1  1/6 (16.67%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 1/11 (9.09%)  1 5/21 (23.81%)  8
Dysphonia  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 1/21 (4.76%)  1
Dyspnoea  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 4/21 (19.05%)  4
Haemoptysis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Nasal congestion  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  2
Rales  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Wheezing  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders           
Decubitus ulcer  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 2/21 (9.52%)  2
Dermatitis contact  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Dry skin  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Erythema  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Hyperhidrosis  1  0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/11 (9.09%)  1 1/21 (4.76%)  1
Pain of skin  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Papule  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Pruritus  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 0/21 (0.00%)  0
Rash macular  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Rash papular  1  1/6 (16.67%)  2 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Vascular disorders           
Flushing  1  0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Hot flush  1  1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 0/21 (0.00%)  0
Hypertension  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/11 (0.00%)  0 3/21 (14.29%)  5
Hypotension  1  0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/11 (9.09%)  1 1/21 (4.76%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01288989    
Other Study ID Numbers: 14247
CP23-1001 ( Other Identifier: ImClone Systems )
I5G-IE-JBCA ( Other Identifier: Eli Lilly and Company )
First Submitted: January 31, 2011
First Posted: February 3, 2011
Results First Submitted: March 11, 2019
Results First Posted: June 17, 2019
Last Update Posted: June 17, 2019