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| ID | Type | Description | Link |
|---|---|---|---|
| CP20-0801 | Other Identifier | ImClone Systems | |
| I4Y-IE-JCDB | Other Identifier | Eli Lilly and Company |
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The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid [FA] + fluorouracil [5-FU] + oxaliplatin [mFOLFOX-6])-based regimens, as second-line therapy.
During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mFOLFOX-6 | Active Comparator | mFOLFOX-6 |
|
| mFOLFOX-6 + Ramucirumab | Experimental | mFOLFOX-6 + Ramucirumab |
|
| mFOLFOX-6 + Icrucumab | Experimental | mFOLFOX-6 + Icrucumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab | Biological | 8 mg/kg IV Q2W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit. | Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression. |
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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 |
|---|---|---|---|---|---|---|
| ImClone Investigational Site | Cincinnati | Ohio | 45242 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27733377 | Derived | Moore M, Gill S, Asmis T, Berry S, Burkes R, Zbuk K, Alcindor T, Jeyakumar A, Chan T, Rao S, Spratlin J, Tang PA, Rothenstein J, Chan E, Bendell J, Kudrik F, Kauh J, Tang S, Gao L, Kambhampati SR, Nasroulah F, Yang L, Ramdas N, Binder P, Strevel E. Randomized phase II study of modified FOLFOX-6 in combination with ramucirumab or icrucumab as second-line therapy in patients with metastatic colorectal cancer after disease progression on first-line irinotecan-based therapy. Ann Oncol. 2016 Dec;27(12):2216-2224. doi: 10.1093/annonc/mdw412. Epub 2016 Oct 11. |
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Completers were defined as participants who had failure event (progressive disease, death), or were off treatment and censored due to study completion.
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| ID | Title | Description |
|---|---|---|
| FG000 | mFOLFOX-6 | mFOLFOX-6: Oxaliplatin: 85 milligram/meter squared, intravenous (mg/m², IV) infusion every 2 weeks (Q2W) Folinic acid (FA): 400 mg/m² IV infusion Q2W (or Levo-folinic acid [LFA]: 200 mg/m² Q2 weeks if FA is unavailable). Fluorouracil (5FU): 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W |
| FG001 | mFOLFOX-6 + Ramucirumab | mFOLFOX-6 + Ramucirumab Ramucirumab: 8 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV infusion Q2W |
| FG002 | mFOLFOX-6 + Icrucumab | mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | mFOLFOX-6 | mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
| BG001 | mFOLFOX-6 + Ramucirumab |
| 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 | Progression-Free Survival (PFS) | PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit. | Modified Intent-to-Treatment (mITT) population includes all the randomized participants who received at least one dose study drug. In mFOLFOX-6, mFOLFOX-6+Ramucirumab and mFOLFOX-6 + Icrucumab, there were 13, 9 and 11 censored participants, respectively. | Posted | Median | 95% Confidence Interval | Weeks | Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks) |
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All randomized participants who received at least one dose of study drug.
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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 | mFOLFOX-6 | mFOLFOX-6 mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Compnay | 800-545-5979 |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| C000626257 | Icrucumab |
| C548516 | IMC-18F1 |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Icrucumab | Biological | 15 mg/kg IV Q2W |
|
|
| mFOLFOX-6 | Drug | Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W) FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
|
| Baseline until Disease Progression (Up to 95 Weeks) |
| Overall Survival (OS) | Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. | Baseline Until Death from Any Cause (Up to 163 Weeks) |
| Duration of Response (DoR) | DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to < 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.) | Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks) |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5 | Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum. | Cycle 5, 1 Hour Post End of Infusion |
| Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5 | Trough (prior to infusion, Ctrough) concentrations measured in serum. | Cycle 5, Prior to Infusion |
| Maximum Concentration (Cmax) at Day 8 | Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion. | Day 8 (cycles 1 and 5) |
| Maximum Concentration (Cmax) at Day 15 | Cmax is the maximum peak concentration measured in blood plasma after drug infusion. | Day 15 (Cycles 1 and 5) |
| Minimum Concentration (Cmin) at Day 1 | Cmin is the minimum peak concentration measured in blood plasma after drug infusion. | Day 1 (cycles 1, 5, 9, and 13) |
| Minimum Concentration (Cmin) at Day 4 | Cmin is the minimum peak concentration measured in blood plasma after drug infusion. | Day 4 (cycles 1 and 5) |
| Minimum Concentration (Cmin) at Day 8 | Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion. | Day 8 (cycles 1 and 5) |
| Minimum Concentration (Cmin) at Day 15 | Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion. | Day 15 (cycles 1 and 5) |
| Number of Participants With Serum Ramucirumab Antibody Assessment | A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals. | 31 Weeks |
| Serum Anti-Icrucumab Antibody Assessment | A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals. | 31 Weeks |
| Number of Participants With Adverse Events | A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module. | Baseline up to 165 weeks |
| Columbia |
| South Carolina |
| 29210 |
| United States |
| ImClone Investigational Site | Nashville | Tennessee | 37232 | United States |
| ImClone Investigational Site | Calgary | Alberta | T2N 4N2 | Canada |
| ImClone Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| ImClone Investigational Site | Kelowna | British Columbia | V1Y 5L3 | Canada |
| ImClone Investigational Site | Surrey | British Columbia | V3V 1Z2 | Canada |
| ImClone Investigational Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| ImClone Investigational Site | Halifax | Nova Scotia | B3H 1V7 | Canada |
| ImClone Investigational Site | Hamilton | Ontario | L8V 5C2 | Canada |
| ImClone Investigational Site | London | Ontario | N6A 4L6 | Canada |
| ImClone Investigational Site | Mississauga | Ontario | L5M 2N1 | Canada |
| ImClone Investigational Site | Oshawa | Ontario | L1G 2B9 | Canada |
| ImClone Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| ImClone Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| ImClone Investigational Site | Windsor | Ontario | N8W 2X3 | Canada |
| ImClone Investigational Site | Montreal | Quebec | H2W 156 | Canada |
| Withdrawal by Subject |
|
| Death |
|
| Met Exclusion Criteria |
|
mFOLFOX-6 + Ramucirumab
Ramucirumab: 8 mg/kg IV Q2W
mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W
FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W
| BG002 | mFOLFOX-6 + Icrucumab | mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m2 Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| ID | Title | Description |
|---|---|---|
| OG000 | mFOLFOX-6 | mFOLFOX-6: Oxaliplatin: 85 per meter squared (mg/m²) IV Q2W FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
| OG001 | mFOLFOX-6 + Ramucirumab | mFOLFOX-6 + Ramucirumab Ramucirumab: 8 mg/kg IV infusion Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV Q2W FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
| OG002 | mFOLFOX-6 + Icrucumab | mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg IV Q2W mFOLFOX-6: Oxaliplatin: 85 mg/m² IV infusion Q2W FA: 400 mg/m² IV infusion Q2 weeks (or LFA: 200 mg/m² Q2W if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W |
|
|
| Secondary | Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) | The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes [target or non-target] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression. | mITT population includes all the randomized participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline until Disease Progression (Up to 95 Weeks) |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive. | mITT population includes all the randomized participants who received at least one dose of study drug. In mFOLFOX-6, mFOLFOX-6 + Ramucirumab, and mFOLFOX-6 + Icrucumab there were 12, 11, and 12 censored participants, respectively. | Posted | Median | 95% Confidence Interval | Weeks | Baseline Until Death from Any Cause (Up to 163 Weeks) |
|
|
|
| Secondary | Duration of Response (DoR) | DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to < 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.) | mITT population includes all the randomized participants who received at least one dose of study drug and had evaluable baseline and post baseline DoR data. 2 participants were censored in mFOLFOX-6 arm, 2 in mFOLFOX-6 + Ramucirumab arm and 1 in mFOLFOX-6 + Icrucumab. | Posted | Median | 95% Confidence Interval | Weeks | Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks) |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5 | Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum. | All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable ramucirumab or icrucumab PK data to calculate Cmax. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/milliliter (µg/mL) | Cycle 5, 1 Hour Post End of Infusion |
|
|
|
| Secondary | Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5 | Trough (prior to infusion, Ctrough) concentrations measured in serum. | All randomized participants assigned to the mFOLFOX-6 + Ramucirumab or mFOLFOX-6 + Icrucumab who received at least one dose of study drug and had evaluable Ramucirumab or Icrucumab PK data to calculate Ctrough. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Cycle 5, Prior to Infusion |
|
|
|
| Secondary | Maximum Concentration (Cmax) at Day 8 | Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion. | Zero participants analyzed. Outcome Measure (OM) entered incorrectly and no data collected to report. | Posted | Day 8 (cycles 1 and 5) |
|
|
| Secondary | Maximum Concentration (Cmax) at Day 15 | Cmax is the maximum peak concentration measured in blood plasma after drug infusion. | Zero participants analyzed. OM entered incorrectly and no data collected to report. | Posted | Day 15 (Cycles 1 and 5) |
|
|
| Secondary | Minimum Concentration (Cmin) at Day 1 | Cmin is the minimum peak concentration measured in blood plasma after drug infusion. | Zero participants analyzed. OM entered incorrectly and no data collected to report. | Posted | Day 1 (cycles 1, 5, 9, and 13) |
|
|
| Secondary | Minimum Concentration (Cmin) at Day 4 | Cmin is the minimum peak concentration measured in blood plasma after drug infusion. | Zero participants analyzed. OM entered incorrectly and no data collected to report. | Posted | Day 4 (cycles 1 and 5) |
|
|
| Secondary | Minimum Concentration (Cmin) at Day 8 | Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion. | Zero participants analyzed. OM entered incorrectly and no data collected to report. | Posted | Day 8 (cycles 1 and 5) |
|
|
| Secondary | Minimum Concentration (Cmin) at Day 15 | Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion. | Zero participants analyzed. OM entered incorrectly and no data collected to report. | Posted | Day 15 (cycles 1 and 5) |
|
|
| Secondary | Number of Participants With Serum Ramucirumab Antibody Assessment | A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals. | Participants in mFOLFOX-6 +Ramucirumab who received at least one dose of study drug and had at least 1 post treatment assessment. | Posted | Count of Participants | Participants | No | 31 Weeks |
|
|
|
| Secondary | Serum Anti-Icrucumab Antibody Assessment | A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals. | Zero participants analyzed. No data collected to report. | Posted | 31 Weeks |
|
|
| Secondary | Number of Participants With Adverse Events | A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module. | Population includes all the randomized participants who received at least one dose study drug. | Posted | Count of Participants | Participants | No | Baseline up to 165 weeks |
|
|
|
| 37 |
| 49 |
| 11 |
| 49 |
| 48 |
| 49 |
| EG001 | mFOLFOX-6 + Ramucirumab | mFOLFOX-6 + Ramucirumab Ramucirumab : 8 mg/kg I.V. infusion, administered every 2 weeks mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks | 41 | 52 | 18 | 52 | 52 | 52 |
| EG002 | mFOLFOX-6 + Icrucumab | mFOLFOX-6 + Icrucumab Icrucumab: 15 mg/kg I.V. infusion, administered every 2 weeks mFOLFOX-6: Oxaliplatin: 85 mg/m² I.V. infusion q2 weeks FA: 400 mg/m² I.V. infusion q2 weeks (or LFA: 200 mg/m2 q2 weeks if FA is unavailable). 5FU: 400 mg/m² bolus + 2400 mg/m² I.V. infusion q2 weeks | 40 | 52 | 12 | 52 | 52 | 52 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Intestinal perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenic infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Medication error | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Stent occlusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ureteric obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Face oedema | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Temperature intolerance | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Periorbital oedema | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
Not provided
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Any Grade ≥3 AE |
|
| Any AE leading to discontinuation (any drug) |
|