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| ID | Type | Description | Link |
|---|---|---|---|
| CP20-0903 | Other Identifier | ImClone LLC | |
| I4Y-IE-JCDD | Other Identifier | Eli Lilly and Company |
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An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxane therapy receive ramucirumab DP or Icrucumab (IMC-18F1) administered on an every-21-day cycle (in combination with oral capecitabine therapy; capecitabine is administered twice a day on Days 1-14 of each cycle). Approximately 150 participants will be randomized in a 1:1:1 ratio to either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine (Arm A and Arm B, respectively) or capecitabine monotherapy (Arm C). Randomization will be stratified by triple-negative receptor status (estrogen receptor-negative, progesterone receptor-negative, and human epidermal growth factor receptor-2 [HER2/neu]-negative) (yes/no) and receipt of prior antiangiogenic therapy.
Treatment with the study medication(s) will continue until disease progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision. Capecitabine dose reductions in the setting of significant myelosuppression, hand-and-foot syndrome, or diarrhea will be required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramucirumab DP + Capecitabine | Experimental | Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. |
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| Icrucumab + Capecitabine | Experimental | Cycles repeat until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. |
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| Capecitabine* | Active Comparator | Crossover Study: * At the discretion of the investigator, participants will be eligible to receive either ramucirumab DP or Icrucumab (IMC-18F1) in combination with capecitabine, after radiographic disease progression while on capecitabine. The investigator will decide which investigational product will be given. Cycles repeat every 21 days until disease progression, the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the participant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ramucirumab DP | Biological | 10 mg/kg I.V. Day 1 of every-21-day cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment. | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as the time from the date of randomization 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. | From Date of Randomization until Death Due to Any Cause (Up To 160 weeks) |
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Inclusion Criteria:
The participant has histologically or cytologically confirmed breast cancer which at the time of study entry is either Stage III disease not amenable to curative therapy or Stage IV disease
Has measurable or nonmeasurable disease
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has received prior anthracycline therapy
Has received prior taxane therapy
Participants with human epidermal growth factor receptor-2 (HER2) positive disease must have progressed on or following trastuzumab
Participants with hormone receptor-positive disease must have progressed on or following hormone therapy
Has received ≤ 3 prior chemotherapy regimens in any setting (a regimen is defined as any agent[s] that has been administered for more than 1 cycle; sequential neoadjuvant/adjuvant treatment is considered 1 regimen)
Has completed any prior radiotherapy ≥ 4 weeks prior to randomization
Has completed any prior hormonal therapy ≥ 2 weeks prior to randomization
Has adverse events (AEs) that have resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or hormonal therapy
Has adequate hematologic, coagulation, hepatic and renal function
Does not have:
Has urinary protein is ≤ 1+ on dipstick or routine urinalysis; if urine protein ≥ 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication
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 | Scottsdale | Arizona | 85259 | United States | ||
| ImClone Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28220020 | Derived | Vahdat LT, Layman R, Yardley DA, Gradishar W, Salkeni MA, Joy AA, Garcia AA, Ward P, Khatcheressian J, Sparano J, Rodriguez G, Tang S, Gao L, Dalal RP, Kauh J, Miller K. Randomized Phase II Study of Ramucirumab or Icrucumab in Combination with Capecitabine in Patients with Previously Treated Locally Advanced or Metastatic Breast Cancer. Oncologist. 2017 Mar;22(3):245-254. doi: 10.1634/theoncologist.2016-0265. Epub 2017 Feb 20. |
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Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
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Completers are those participants who died or alive and on study at conclusion but off treatment.
Participants in Capecitabine arm were allowed to cross-over to ramucirumab or icrucumab in combination with capecitabine, after radiographic disease progression while on capecitabine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ramucirumab + Capecitabine | Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per square meter (mg/m^2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| FG001 | Icrucumab + Capecitabine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| IMC-18F1 | Biological | 12 mg/kg I.V. Days 1 and 8 of every-21-day cycle |
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| Capecitabine | Drug | 1000 mg/m^2 orally Twice a day for 14 days |
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| Percentage of Participants With Objective Response Rate (ORR) | The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. | From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks) |
| Duration of Response | Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks) |
| Number of Participants With Adverse Events (AEs) | Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Up To 160 Weeks |
| Number of Participants With Serious Adverse Events (SAEs) | SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | Up To 160 Weeks |
| Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab | Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab. | Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab | Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab. | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Terminal Half-life (t½) of Ramucirumab or Icrucumab | Terminal half-life (t½) of Ramucirumab and Icrucumab. | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Clearance (Cl) of Ramucirumab or Icrucumab | Clearance (Cl) of Ramucirumab and Icrucumab. | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab | Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab. | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
| Los Angeles |
| California |
| 90033 |
| United States |
| ImClone Investigational Site | Jacksonville | Florida | 32224 | United States |
| ImClone Investigational Site | Atlanta | Georgia | 30322 | United States |
| ImClone Investigational Site | Augusta | Georgia | 30912 | United States |
| ImClone Investigational Site | Chicago | Illinois | 60611 | United States |
| ImClone Investigational Site | Indianapolis | Indiana | 46202 | United States |
| ImClone Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| ImClone Investigational Site | New York | New York | 10021 | United States |
| ImClone Investigational Site | Stony Brook | New York | 11794 | United States |
| ImClone Investigational Site | The Bronx | New York | 10461 | United States |
| ImClone Investigational Site | Washington | North Carolina | 27889 | United States |
| ImClone Investigational Site | Cincinnati | Ohio | 45242 | United States |
| ImClone Investigational Site | Columbus | Ohio | 43219 | United States |
| ImClone Investigational Site | Dallas | Texas | 75390 | United States |
| ImClone Investigational Site | San Antonio | Texas | 78229 | United States |
| ImClone Investigational Site | Salt Lake City | Utah | 84106 | United States |
| ImClone Investigational Site | Richmond | Virginia | 23230 | United States |
| ImClone Investigational Site | Spokane | Washington | 99208 | United States |
| ImClone Investigational Site | Morgantown | West Virginia | 26506 | United States |
| ImClone Investigational Site | Calgary | Alberta | T2N 4N2 | Canada |
| ImClone Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| ImClone Investigational Site | Toronto | Ontario | M4N 3M5 | Canada |
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| FG002 | Capecitabine | Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab; Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| Received at Least One Dose of Study Drug |
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| Capecitabine Crossover to Ramucirumab |
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| Capecitabine Crossover to Icrucumab |
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| COMPLETED |
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| NOT COMPLETED |
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All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ramucirumab + Capecitabine | Participants received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| BG001 | Icrucumab + Capecitabine | Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| BG002 | Capecitabine | Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab; Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-Free Survival (PFS) | PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) and the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up, or had missed 2 or more scheduled tumor assessments were censored at the day of their last adequate tumor assessment. | All randomized participants who received at least one dose of study drug; Censored participants: Ramucirumab + Capecitabine = 12; Icrucumab + Capecitabine = 11; Capecitabine = 7 | Posted | Median | 95% Confidence Interval | Weeks | From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 97 weeks) |
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| Secondary | Overall Survival (OS) | Overall survival is defined as the time from the date of randomization 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. | All randomized participants who received at least one dose of study drug; censored participants: Ramucirumab + Capecitabine = 21; Icrucumab + Capecitabine = 17; Capecitabine = 22 Participants were analyzed as per the randomization. | Posted | Median | 95% Confidence Interval | Weeks | From Date of Randomization until Death Due to Any Cause (Up To 160 weeks) |
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| Secondary | Percentage of Participants With Objective Response Rate (ORR) | The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm and the appearance of ≥1 new lesions was progression. | All randomized participants who received at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From Date of Randomization until Disease Progression/Recurrence (Up to 97 weeks) |
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| Secondary | Duration of Response | Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that the criteria for progressive disease (PD) is met (taking as a reference for PD that smallest measurement recorded since the treatment started), or death, is objectively documented.CR was defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to <10 mm. PR was defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.PD defined as ≥20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). Sum must also have demonstrated an absolute increase of ≥5 mm, or the appearance of 1 or more new lesions was considered progression. | All randomized participants who received at least one dose of study drug and had CR/PR. | Posted | Median | 95% Confidence Interval | weeks | From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 97 weeks) |
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| Secondary | Number of Participants With Adverse Events (AEs) | Adverse event (AE) will be regarded as treatment-emergent if onset date occurs any time on or after the administration of the first dose of study treatment up to 30 days after the last dose of study treatment (or up to any time if related to study treatment); or it occurs prior to first dose date and worsens while on therapy or up to 30 days after the last dose of study treatment (or up to any time if related to study treatment). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Up To 160 Weeks |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | SAE was defined as any untoward medical occurrence that at any dose: Resulted in death; Was life-threatening; Required inpatient hospitalization or caused prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity; Was a congenital anomaly/birth defect; Required intervention to prevent permanent impairment/damage; Was an important medical event (defined as a medical event that may not have been immediately life-threatening or resulted in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention to prevent one of the other serious outcomes listed in the definition above). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. | All randomized participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | No | Up To 160 Weeks |
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| Secondary | Maximum Concentration (Cmax) Ramucirumab Drug Product (DP) or Icrucumab | For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram per milliliter | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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| Secondary | Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab | Minimum Concentration (Cmin) Ramucirumab Drug Product (DP) or Icrucumab. | For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Micro gram per milliliter | Cycle 2,4,6,8,0,12,14,16,18,22: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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| Secondary | Area Under the Concentration Versus Time Curve From Time Zero to Infinity of Ramucirumab or Icrucumab | Area Under the Concentration (AUC) Versus Time Curve From Time Zero to Infinity of Ramucirumab and Icrucumab. | For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour/mL | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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| Secondary | Terminal Half-life (t½) of Ramucirumab or Icrucumab | Terminal half-life (t½) of Ramucirumab and Icrucumab. | For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples. | Posted | Geometric Mean | Full Range | Days | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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| Secondary | Clearance (Cl) of Ramucirumab or Icrucumab | Clearance (Cl) of Ramucirumab and Icrucumab. | For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters per hour | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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| Secondary | Volume of Distribution at Steady State (Vss) of Ramucirumab or Icrucumab | Volume of Distribution at Steady State (Vss) of Ramucirumab and Icrucumab. | For ramucirumab, all randomized participants who received at least one dose of study drug & had evaluable pharmacokinetic (PK) samples. For icrucumab, zero participants analyzed as reliable PK parameters could not be estimated using non-compartmental PK analysis due to insufficient number of samples. | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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| Secondary | Number of Participants With Anti-Ramucirumab and Anti-Icrucumab Antibodies | For ramucirumab, Aall randomized participants who received at least one dose of study drug and had evaluable serum samples for antibody assessment. For icrucumab, zero participants analyzed as antibody assessment data was not collected for Icrucumab. | Posted | Count of Participants | Participants | No | Cycle 1: Pre-infusion, 1h, 48h, 72h, 168, 336h post infusion |
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Up To 160 Weeks
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 | Ramucirumab + Capecitabine | Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. | 20 | 52 | 51 | 52 | ||
| EG001 | Icrucumab + Capecitabine | Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. | 25 | 49 | 49 | 49 | ||
| EG002 | Capecitabine | Participants received 1000 mg/m*2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. | 6 | 49 | 48 | 49 | ||
| EG003 | Crossover to Ramucirumab DP + Capecitabine | Participants received 10 milligram per kilogram (mg/kg) Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. | 5 | 29 | 29 | 29 | ||
| EG004 | Crossover to Icrucumab + Capecitabine | Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 milligram per meter square (mg/m*2) of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Haemangioma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Face oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
The disclosure restriction on PI is for five years after the study conclusion/termination, after five years disclosure restriction on PI is that sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000096662 | Ramucirumab |
| C548516 | IMC-18F1 |
| C000626257 | Icrucumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| American Indian or Alaska Native,White |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| White, Other |
|
| Other |
|
| 0.0851 |
| Hazard Ratio (HR) |
| 1.480 |
| 2-Sided |
| 95 |
| 0.938 |
| 2.335 |
| Other |
|
|
|
| OG002 | Capecitabine | Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab; Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
|
|
|
Participants received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
| OG002 | Capecitabine | Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab; Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
|
|
Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab; Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
|
|
| OG002 | Capecitabine | Participants received 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. After radiographic diseases progression while on Capecitabine, participants were crossed-over to either Ramucirumab or Icrucumab; Participants crossed-over to Ramucirumab + Capecitabine had received 10 mg/kg Ramucirumab intravenously on day 1 of 21 days cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. Participants crossed-over to Icrucumab + Capecitabine received 12 mg/kg Icrucumab intravenously on day 1 and day 8 of 21 day cycle along with 1000 mg/m^2 of Capecitabine twice daily orally on days 1 to 14 of 21 days cycle. |
|
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| Participants |
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| Participants |
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