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| ID | Type | Description | Link |
|---|---|---|---|
| CP23-1001 | Other Identifier | ImClone Systems | |
| I5G-IE-JBCA | Other Identifier | Eli Lilly and Company |
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A dose escalation study to determine the safety and maximum tolerated dose (MTD) of IMC-3C5 in subjects with advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available.
This multicenter study will enroll approximately 40 participants. The actual sample size will vary depending on how many participants are needed to obtain at least 3 complete participants per cohort.
IMC-3C5 will initially be administered once every week (Cohorts 1-4) in a dose escalated manner. The starting dose will be 5 mg/kg weekly (Cohort 1). Dose escalation will proceed to 10 mg/kg (Cohort 2), 20 mg/kg (Cohort 3), and 30 mg/kg (Cohort 4). Based on an analysis of the safety and pharmacokinetic profile of weekly dosing, participants may be enrolled sequentially into 2 every-other-week dose cohorts (Cohorts 5-6, 20 mg/kg and 30 mg/kg). Intermediate doses may also be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-3C5 | Experimental | Participants receiving IMC-3C5 intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-3C5 | Biological | Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 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. | Baseline up to 46 months |
| Number of Participants Reporting Dose-Limiting Toxicity (DLT) | 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:
| Baseline up to 16 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Peoria | Illinois | 61615 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27566701 | Derived | Saif MW, Knost JA, Chiorean EG, Kambhampati SR, Yu D, Pytowski B, Qin A, Kauh JS, O'Neil BH. Phase 1 study of the anti-vascular endothelial growth factor receptor 3 monoclonal antibody LY3022856/IMC-3C5 in patients with advanced and refractory solid tumors and advanced colorectal cancer. Cancer Chemother Pharmacol. 2016 Oct;78(4):815-24. doi: 10.1007/s00280-016-3134-3. Epub 2016 Aug 26. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to 46 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 another withdrawal criterion was met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000619939 | LY3022856 |
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| Baseline up to 46 Months |
| Maximum Concentration (Cmax) of IMC-3C5 - First Infusion | 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.) |
| Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion | 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.) |
| Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion | 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.) |
| Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion | 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.) |
| Terminal Half-life (t1/2) of IMC-3C5 - Fourth Infusion | 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.) |
| Volume of Distribution of IMC-3C5 at Steady State (Vss) - Fourth Infusion | 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.) |
| Clearance (Cl) of IMC-3C5 at Steady State - Fourth Infusion | 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.) |
| Minimum Concentration (Cmin) of IMC-3C5 - Fourth Infusion | Trough concentration (Ctrough) prior to fourth infusion of Cycle 1. | Prior to 4th infusion (approximately Day 22) of Cycle 1 for cohorts 1-5. (Cycle 1 = 4 - 6 weeks.) |
| Anti-IMC-3C5 Antibody Assessment | 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.) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Indianapolis | Indiana | 46202 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Boston | Massachusetts | 02111 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | New York | New York | 10029 | United States |
| Dose limiting toxicity |
|
| Adverse Event |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| Primary | Number of Participants Reporting Dose-Limiting Toxicity (DLT) | 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:
| All participants who received at least one dose of study drug. DLT was assessed in cohorts 1-4, only. | Posted | Count of Participants | Participants | No | Baseline up to 16 Months |
|
|
|
| Secondary | Antitumor Activity of Single Agent IMC-3C5: Best Overall Response (BOR) | 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. | All participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Baseline up to 46 Months |
|
|
|
| Secondary | Maximum Concentration (Cmax) of IMC-3C5 - First Infusion | All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | 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.) |
|
|
|
| Secondary | Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Drug Concentration (AUC 0-tlast) of IMC-3C5 - First Infusion | AUC 0-tlast was only measured in participants in cohorts 1-4, who received study drug and had sufficient evaluable AUC 0-tlast values. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter (µg*hr/mL) | 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.) |
|
|
|
| Secondary | Maximum Concentration (Cmax) of IMC-3C5 - Fourth Infusion | All participants who received study drug and had sufficient evaluable Cmax values. For cohort 5, 1-hour post infusion values are presented. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | 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.) |
|
|
|
| Secondary | Area Under the Concentration-Time Curve During One Dose Interval (AUCtau) of IMC-3C5 (168 Hours) - Fourth Infusion | AUCtau was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable AUCtau values. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/milliliter (µg*hr/mL) | 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.) |
|
|
|
| Secondary | Terminal Half-life (t1/2) of IMC-3C5 - Fourth Infusion | t1/2 was estimated in participants in cohorts 1-4 who received study drug and had sufficient evaluable t1/2 values. | Posted | Geometric Mean | Full Range | days | 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.) |
|
|
|
| Secondary | Volume of Distribution of IMC-3C5 at Steady State (Vss) - Fourth Infusion | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | 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.) |
|
|
|
| Secondary | Clearance (Cl) of IMC-3C5 at Steady State - Fourth Infusion | Cl was only measured in participants in cohorts 1-4 who received study drug and had sufficient evaluable Cl values. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liter/hour (L/h) | 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.) |
|
|
|
| Secondary | Minimum Concentration (Cmin) of IMC-3C5 - Fourth Infusion | Trough concentration (Ctrough) prior to fourth infusion of Cycle 1. | All participants who received study drug and had sufficient evaluable Ctrough values. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | Prior to 4th infusion (approximately Day 22) of Cycle 1 for cohorts 1-5. (Cycle 1 = 4 - 6 weeks.) |
|
|
|
| Secondary | Anti-IMC-3C5 Antibody Assessment | Zero participants were analyzed. No assay was available to assess serum anti-IMC-3C5 antibodies. | Posted | 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.) |
|
|
| 2 |
| 6 |
| 6 |
| 6 |
| EG001 | 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 another withdrawal criterion was met. | 1 | 3 | 3 | 3 |
| EG002 | 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 another withdrawal criterion was met. | 1 | 3 | 3 | 3 |
| EG003 | 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 another withdrawal criterion was met. | 5 | 11 | 11 | 11 |
| EG004 | 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 another withdrawal criterion was met. | 7 | 21 | 20 | 21 |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Renal haemorrhage | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Small intestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Medical device pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Candida infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Haematocrit decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 17.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nerve root compression | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Micturition frequency decreased | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 17.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
|
Not provided
| Progressive disease |
|
| Not evaluable |
|