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A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer (RAINFALL)

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ClinicalTrials.gov Identifier: NCT02314117
Recruitment Status : Completed
First Posted : December 10, 2014
Results First Posted : May 2, 2018
Last Update Posted : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Metastatic Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Interventions Drug: Ramucirumab
Drug: Capecitabine
Drug: Cisplatin
Drug: Placebo
Drug: Fluorouracil
Enrollment 645
Recruitment Details  
Pre-assignment Details Completers are defined as participants who died or those who were alive and off treatment when the study completed.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Period Title: Overall Study
Started 326 319
Received at Least One Dose of Study Drug 323 315
Completed 314 303
Not Completed 12 16
Reason Not Completed
Lost to Follow-up             9             14
Withdrawal by Subject             3             2
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine Total
Hide Arm/Group Description 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle. Total of all reporting groups
Overall Number of Baseline Participants 326 319 645
Hide Baseline Analysis Population Description
All randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 326 participants 319 participants 645 participants
58.9  (11.6) 60.1  (11.8) 59.5  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 319 participants 645 participants
Female 112 104 216
Male 214 215 429
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 319 participants 645 participants
Hispanic or Latino 67 62 129
Not Hispanic or Latino 227 245 472
Unknown or Not Reported 32 12 44
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 326 participants 319 participants 645 participants
American Indian or Alaska Native 12 11 23
Asian 38 31 69
Native Hawaiian or Other Pacific Islander 1 0 1
Black or African American 2 3 5
White 256 264 520
More than one race 0 0 0
Unknown or Not Reported 17 10 27
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 326 participants 319 participants 645 participants
Puerto Rico 1 1 2
Argentina 21 22 43
Hungary 15 16 31
United States 42 31 73
Czechia 11 8 19
Japan 32 28 60
United Kingdom 20 22 42
Russia 25 25 50
Spain 10 13 23
Canada 10 6 16
Netherlands 4 7 11
Belgium 8 5 13
Finland 3 5 8
Denmark 12 3 15
Poland 8 10 18
Italy 28 45 73
Mexico 26 26 52
Israel 11 12 23
France 19 21 40
Germany 20 13 33
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.
Time Frame Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
First 508 randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=62.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 255 253
Median (95% Confidence Interval)
Unit of Measure: months
5.72
(5.45 to 6.51)
5.39
(4.47 to 5.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.753
Confidence Interval (2-Sided) 95%
0.607 to 0.935
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.
Time Frame Randomization to Death from Any Cause (Up To 30 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=88.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 326 319
Median (95% Confidence Interval)
Unit of Measure: months
11.17
(9.92 to 11.93)
10.74
(9.53 to 11.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.962
Confidence Interval (2-Sided) 95%
0.801 to 1.156
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression- Free Survival 2 (PFS2)
Hide Description PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST.
Time Frame Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=74 and Placebo + Cisplatin + Capecitabine=74.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 326 319
Median (95% Confidence Interval)
Unit of Measure: months
10.18
(9.03 to 10.84)
9.20
(8.34 to 9.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.926
Confidence Interval (2-Sided) 95%
0.774 to 1.108
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Hide Description Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
Time Frame Randomization to Disease Progression (Up To 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 326 319
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
41.1
(35.8 to 46.4)
36.4
(31.1 to 41.6)
5.Secondary Outcome
Title Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
Hide Description DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
Time Frame Randomization to Disease Progression (Up To 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21 day cycle.
Overall Number of Participants Analyzed 326 319
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.9
(77.7 to 86.1)
76.5
(71.8 to 81.1)
6.Secondary Outcome
Title Time to Progression (TTP)
Hide Description TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
Time Frame Randomization to Disease Progression (Up To 24 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=149 and Placebo + Cisplatin + Capecitabine=111.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21 day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that are unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21 day cycle.
Overall Number of Participants Analyzed 326 319
Median (95% Confidence Interval)
Unit of Measure: months
6.77
(5.88 to 7.66)
5.78
(5.55 to 6.37)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.699
Confidence Interval (2-Sided) 95%
0.569 to 0.859
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Duration of Response (DoR)
Hide Description Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment.
Time Frame Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored : Ramucirumab + Cisplatin + Capecitabine= 23 and Placebo + Cisplatin + Capecitabine=10.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 134 116
Median (95% Confidence Interval)
Unit of Measure: months
5.72
(5.09 to 6.34)
4.27
(3.88 to 4.90)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.657
Confidence Interval (2-Sided) 95%
0.499 to 0.866
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
Hide Description Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.
Time Frame Randomization, First worsening in QoL (Up To 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=215 and Placebo + Cisplatin + Capecitabine=217
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 326 319
Median (95% Confidence Interval)
Unit of Measure: months
9.00
(8.08 to 12.58)
9.46
(6.74 to 11.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.013
Confidence Interval (2-Sided) 95%
0.770 to 1.332
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)
Hide Description The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Time Frame Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who provided data at baseline and cycle 6.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 136 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
EQ-5D index -0.008  (0.148) -0.010  (0.157)
EQ-5D VAS 0.8  (18.56) 1.5  (20.33)
10.Secondary Outcome
Title Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Hide Description The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.
Time Frame Randomization to ECOG PS ≥2 (Up To 26 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=254 and Placebo + Cisplatin + Capecitabine= 260.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 326 319
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(12.2 to NA)
NA [1] 
(NA to NA)
[1]
Very few events occurred therefore data were not assessable.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ramucirumab + Cisplatin + Capecitabine, Placebo + Cisplatin + Capecitabine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.117
Confidence Interval (2-Sided) 95%
0.790 to 1.580
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants With Anti-Ramucirumab Antibodies
Hide Description Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.
Time Frame Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of study drug.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine Placebo + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 323 315
Measure Type: Count of Participants
Unit of Measure: Participants
4 5
12.Secondary Outcome
Title Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Hide Description Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Time Frame Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ramucirumab and had evaluable PK data.
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 283
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram/milliliter (µg/mL)
Cycle 1, Day 1 Number Analyzed 283 participants
133
(31%)
Cycle 3, Day 1 Number Analyzed 146 participants
173
(35%)
Cycle 9, Day 1 Number Analyzed 16 participants
169
(60%)
13.Secondary Outcome
Title PK: Minimum Concentration (Cmin) of Ramucirumab
Hide Description Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Time Frame Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received ramucirumab and had evaluable PK data
Arm/Group Title Ramucirumab + Cisplatin + Capecitabine
Hide Arm/Group Description:
8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Overall Number of Participants Analyzed 268
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Cycle 1, Day 8 Number Analyzed 268 participants
40.7
(35%)
Cycle 2, Day 1 Number Analyzed 232 participants
35.7
(56%)
Cycle 3, Day 1 Number Analyzed 163 participants
51.2
(47%)
Cycle 5, Day 1 Number Analyzed 85 participants
69.7
(52%)
Cycle 9, Day 1 Number Analyzed 21 participants
77.6
(98%)
Time Frame Baseline Up To 5.6 Years
Adverse Event Reporting Description All participants who received at least one dose of study drug.
 
Arm/Group Title LY3009806+Capecitabine+Cisplatin Placebo+Capecitabine+Cisplatin
Hide Arm/Group Description 8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.
All-Cause Mortality
LY3009806+Capecitabine+Cisplatin Placebo+Capecitabine+Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
LY3009806+Capecitabine+Cisplatin Placebo+Capecitabine+Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   161/323 (49.85%)      150/315 (47.62%)    
Blood and lymphatic system disorders     
Anaemia † 1  11/323 (3.41%)  11 11/315 (3.49%)  16
Blood loss anaemia † 1  0/323 (0.00%)  0 1/315 (0.32%)  3
Bone marrow failure † 1  1/323 (0.31%)  2 1/315 (0.32%)  1
Febrile neutropenia † 1  5/323 (1.55%)  5 11/315 (3.49%)  13
Haemolytic anaemia † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Leukopenia † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Neutropenia † 1  2/323 (0.62%)  6 8/315 (2.54%)  9
Pancytopenia † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Thrombocytopenia † 1  2/323 (0.62%)  2 1/315 (0.32%)  1
Cardiac disorders     
Acute myocardial infarction † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Angina pectoris † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Arrhythmia † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Arrhythmia supraventricular † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Atrial fibrillation † 1  2/323 (0.62%)  2 2/315 (0.63%)  2
Atrioventricular block complete † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Cardiac arrest † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Cardiac disorder † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Cardiogenic shock † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Pericardial effusion † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Sinus bradycardia † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Sinus node dysfunction † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Supraventricular extrasystoles † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Tachycardia † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Eye disorders     
Retinal vein thrombosis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Gastrointestinal disorders     
Abdominal distension † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Abdominal pain † 1  13/323 (4.02%)  16 7/315 (2.22%)  10
Abdominal pain upper † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Abdominal rigidity † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Acute abdomen † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Ascites † 1  3/323 (0.93%)  3 2/315 (0.63%)  2
Colitis † 1  1/323 (0.31%)  1 3/315 (0.95%)  3
Constipation † 1  3/323 (0.93%)  5 0/315 (0.00%)  0
Diarrhoea † 1  11/323 (3.41%)  13 19/315 (6.03%)  20
Dysphagia † 1  8/323 (2.48%)  9 7/315 (2.22%)  8
Enteritis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Enterocolitis † 1  2/323 (0.62%)  2 0/315 (0.00%)  0
Enterocutaneous fistula † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Erosive oesophagitis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Gastric haemorrhage † 1  5/323 (1.55%)  5 3/315 (0.95%)  3
Gastric perforation † 1  9/323 (2.79%)  9 1/315 (0.32%)  1
Gastric ulcer haemorrhage † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Gastric ulcer perforation † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Gastrointestinal haemorrhage † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Gastrointestinal obstruction † 1  0/323 (0.00%)  0 1/315 (0.32%)  2
Haematemesis † 1  1/323 (0.31%)  1 3/315 (0.95%)  3
Haematochezia † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Hiatus hernia † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Ileus † 1  2/323 (0.62%)  3 3/315 (0.95%)  5
Ileus paralytic † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Impaired gastric emptying † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Inguinal hernia † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Intestinal obstruction † 1  4/323 (1.24%)  7 0/315 (0.00%)  0
Intestinal perforation † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Intra-abdominal haemorrhage † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Large intestinal stenosis † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Large intestine perforation † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Lower gastrointestinal haemorrhage † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Melaena † 1  0/323 (0.00%)  0 2/315 (0.63%)  3
Nausea † 1  5/323 (1.55%)  5 8/315 (2.54%)  10
Obstruction gastric † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Oesophageal fistula † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Oesophageal haemorrhage † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Oesophageal stenosis † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Pneumoperitoneum † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Rectal haemorrhage † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Small intestinal obstruction † 1  0/323 (0.00%)  0 2/315 (0.63%)  3
Small intestinal perforation † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Stomatitis † 1  4/323 (1.24%)  4 2/315 (0.63%)  2
Subileus † 1  4/323 (1.24%)  5 0/315 (0.00%)  0
Upper gastrointestinal haemorrhage † 1  3/323 (0.93%)  5 1/315 (0.32%)  2
Vomiting † 1  14/323 (4.33%)  15 22/315 (6.98%)  27
General disorders     
Asthenia † 1  3/323 (0.93%)  3 2/315 (0.63%)  2
Complication associated with device † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Death † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Device occlusion † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Fall † 1  2/323 (0.62%)  2 1/315 (0.32%)  1
Fatigue † 1  1/323 (0.31%)  1 3/315 (0.95%)  3
General physical health deterioration † 1  6/323 (1.86%)  7 5/315 (1.59%)  5
Heparin-induced thrombocytopenia † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Impaired healing † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Infusion related reaction † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Malaise † 1  3/323 (0.93%)  4 1/315 (0.32%)  1
Mucosal inflammation † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Multiple organ dysfunction syndrome † 1  0/323 (0.00%)  0 3/315 (0.95%)  4
Non-cardiac chest pain † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Pain † 1  0/323 (0.00%)  0 1/315 (0.32%)  2
Pyrexia † 1  2/323 (0.62%)  2 12/315 (3.81%)  12
Sudden death † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Hepatobiliary disorders     
Bile duct obstruction † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Cholangitis † 1  0/323 (0.00%)  0 2/315 (0.63%)  3
Hepatic failure † 1  0/323 (0.00%)  0 3/315 (0.95%)  3
Hyperbilirubinaemia † 1  2/323 (0.62%)  2 0/315 (0.00%)  0
Immune system disorders     
Hypersensitivity † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Infections and infestations     
Biliary tract infection † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Cellulitis † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Cystitis bacterial † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Device related infection † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Device related sepsis † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Enterocolitis infectious † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Gastroenteritis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Infection † 1  2/323 (0.62%)  2 0/315 (0.00%)  0
Lower respiratory tract infection † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Periodontitis † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Periorbital infection † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Peritonitis † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Pharyngitis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Pneumonia † 1  5/323 (1.55%)  5 7/315 (2.22%)  7
Pneumonia bacterial † 1  0/323 (0.00%)  0 1/315 (0.32%)  2
Pseudomembranous colitis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Pseudomonas infection † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Pyelonephritis † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Sepsis † 1  4/323 (1.24%)  5 5/315 (1.59%)  5
Septic shock † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Vascular device infection † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Device dislocation † 1  1/323 (0.31%)  1 3/315 (0.95%)  3
Gastrointestinal stoma complication † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Skin laceration † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Vascular access complication † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Investigations     
Alanine aminotransferase increased † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Aspartate aminotransferase increased † 1  0/323 (0.00%)  0 1/315 (0.32%)  2
Blood bilirubin increased † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Blood creatinine increased † 1  2/323 (0.62%)  2 0/315 (0.00%)  0
Blood potassium decreased † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Body temperature increased † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Creatinine renal clearance decreased † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Neutrophil count decreased † 1  2/323 (0.62%)  2 2/315 (0.63%)  2
Platelet count decreased † 1  2/323 (0.62%)  2 1/315 (0.32%)  1
Weight decreased † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
White blood cell count decreased † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Metabolism and nutrition disorders     
Cachexia † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Decreased appetite † 1  5/323 (1.55%)  6 3/315 (0.95%)  3
Dehydration † 1  7/323 (2.17%)  9 9/315 (2.86%)  9
Hypercalcaemia † 1  0/323 (0.00%)  0 1/315 (0.32%)  2
Hyperglycaemia † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Hyperkalaemia † 1  0/323 (0.00%)  0 1/315 (0.32%)  3
Hypocalcaemia † 1  0/323 (0.00%)  0 2/315 (0.63%)  3
Hypokalaemia † 1  1/323 (0.31%)  1 4/315 (1.27%)  5
Hypomagnesaemia † 1  1/323 (0.31%)  1 1/315 (0.32%)  3
Hyponatraemia † 1  6/323 (1.86%)  10 2/315 (0.63%)  2
Hypophosphataemia † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Malnutrition † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Musculoskeletal and connective tissue disorders     
Back pain † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Osteonecrosis † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colorectal cancer † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Malignant pleural effusion † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Metastases to peritoneum † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Tumour associated fever † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Tumour haemorrhage † 1  1/323 (0.31%)  1 1/315 (0.32%)  2
Nervous system disorders     
Cerebral infarction † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Cerebrovascular accident † 1  1/323 (0.31%)  1 3/315 (0.95%)  3
Cognitive disorder † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Dizziness † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Haemorrhage intracranial † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Ischaemic stroke † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Nervous system disorder † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Presyncope † 1  1/323 (0.31%)  2 0/315 (0.00%)  0
Syncope † 1  2/323 (0.62%)  2 1/315 (0.32%)  1
Psychiatric disorders     
Confusional state † 1  1/323 (0.31%)  1 2/315 (0.63%)  2
Delirium † 1  1/323 (0.31%)  2 1/315 (0.32%)  1
Depression † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Renal and urinary disorders     
Acute kidney injury † 1  10/323 (3.10%)  10 8/315 (2.54%)  13
Hydronephrosis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Nephritis † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Nephropathy † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Proteinuria † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Pyelocaliectasis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Renal colic † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Renal failure † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Renal impairment † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Urinary retention † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Urinary tract obstruction † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Dyspnoea † 1  5/323 (1.55%)  6 2/315 (0.63%)  2
Hiccups † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Hypoxia † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Lung disorder † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Pleural effusion † 1  0/323 (0.00%)  0 3/315 (0.95%)  3
Pneumonia aspiration † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Pneumonitis † 1  0/323 (0.00%)  0 2/315 (0.63%)  2
Pneumothorax † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Pneumothorax spontaneous † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Pulmonary embolism † 1  7/323 (2.17%)  7 9/315 (2.86%)  9
Respiratory failure † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatomyositis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Palmar-plantar erythrodysaesthesia syndrome † 1  2/323 (0.62%)  3 0/315 (0.00%)  0
Skin disorder † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Vascular disorders     
Arterial thrombosis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Brachiocephalic vein thrombosis † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Circulatory collapse † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Deep vein thrombosis † 1  5/323 (1.55%)  5 3/315 (0.95%)  3
Embolism arterial † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Embolism venous † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Hypertension † 1  2/323 (0.62%)  2 0/315 (0.00%)  0
Hypotension † 1  2/323 (0.62%)  2 3/315 (0.95%)  3
Hypovolaemic shock † 1  1/323 (0.31%)  1 1/315 (0.32%)  1
Orthostatic hypotension † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Phlebitis deep † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Subclavian vein thrombosis † 1  0/323 (0.00%)  0 1/315 (0.32%)  2
Thrombophlebitis superficial † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
Venous thrombosis † 1  1/323 (0.31%)  1 0/315 (0.00%)  0
Venous thrombosis limb † 1  0/323 (0.00%)  0 1/315 (0.32%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 23.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY3009806+Capecitabine+Cisplatin Placebo+Capecitabine+Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   315/323 (97.52%)      304/315 (96.51%)    
Blood and lymphatic system disorders     
Anaemia † 1  104/323 (32.20%)  276 114/315 (36.19%)  289
Neutropenia † 1  71/323 (21.98%)  218 74/315 (23.49%)  133
Thrombocytopenia † 1  41/323 (12.69%)  106 26/315 (8.25%)  51
Ear and labyrinth disorders     
Tinnitus † 1  23/323 (7.12%)  26 27/315 (8.57%)  32
Gastrointestinal disorders     
Abdominal pain † 1  52/323 (16.10%)  80 51/315 (16.19%)  69
Abdominal pain upper † 1  22/323 (6.81%)  27 15/315 (4.76%)  22
Constipation † 1  104/323 (32.20%)  161 78/315 (24.76%)  107
Diarrhoea † 1  108/323 (33.44%)  175 107/315 (33.97%)  175
Dyspepsia † 1  19/323 (5.88%)  20 12/315 (3.81%)  14
Dysphagia † 1  21/323 (6.50%)  33 17/315 (5.40%)  23
Nausea † 1  205/323 (63.47%)  459 186/315 (59.05%)  444
Stomatitis † 1  67/323 (20.74%)  110 39/315 (12.38%)  64
Vomiting † 1  134/323 (41.49%)  249 117/315 (37.14%)  217
General disorders     
Asthenia † 1  44/323 (13.62%)  133 40/315 (12.70%)  101
Fatigue † 1  153/323 (47.37%)  316 145/315 (46.03%)  309
Mucosal inflammation † 1  20/323 (6.19%)  31 17/315 (5.40%)  41
Oedema peripheral † 1  45/323 (13.93%)  65 33/315 (10.48%)  46
Pyrexia † 1  28/323 (8.67%)  37 40/315 (12.70%)  56
Infections and infestations     
Upper respiratory tract infection † 1  8/323 (2.48%)  11 17/315 (5.40%)  18
Investigations     
Alanine aminotransferase increased † 1  19/323 (5.88%)  29 10/315 (3.17%)  15
Aspartate aminotransferase increased † 1  20/323 (6.19%)  25 12/315 (3.81%)  17
Blood creatinine increased † 1  31/323 (9.60%)  60 28/315 (8.89%)  41
Neutrophil count decreased † 1  103/323 (31.89%)  295 92/315 (29.21%)  263
Platelet count decreased † 1  72/323 (22.29%)  254 33/315 (10.48%)  75
Weight decreased † 1  54/323 (16.72%)  72 37/315 (11.75%)  56
White blood cell count decreased † 1  37/323 (11.46%)  118 32/315 (10.16%)  109
Metabolism and nutrition disorders     
Decreased appetite † 1  130/323 (40.25%)  245 100/315 (31.75%)  190
Dehydration † 1  19/323 (5.88%)  25 25/315 (7.94%)  30
Hypoalbuminaemia † 1  17/323 (5.26%)  28 13/315 (4.13%)  21
Hypocalcaemia † 1  20/323 (6.19%)  23 11/315 (3.49%)  21
Hypokalaemia † 1  36/323 (11.15%)  51 40/315 (12.70%)  68
Hypomagnesaemia † 1  36/323 (11.15%)  47 45/315 (14.29%)  97
Hyponatraemia † 1  18/323 (5.57%)  30 17/315 (5.40%)  21
Musculoskeletal and connective tissue disorders     
Back pain † 1  28/323 (8.67%)  33 16/315 (5.08%)  20
Nervous system disorders     
Dizziness † 1  36/323 (11.15%)  42 35/315 (11.11%)  52
Dysgeusia † 1  34/323 (10.53%)  38 27/315 (8.57%)  31
Headache † 1  43/323 (13.31%)  57 27/315 (8.57%)  36
Neuropathy peripheral † 1  20/323 (6.19%)  30 8/315 (2.54%)  9
Peripheral sensory neuropathy † 1  39/323 (12.07%)  62 31/315 (9.84%)  41
Psychiatric disorders     
Insomnia † 1  27/323 (8.36%)  29 25/315 (7.94%)  27
Renal and urinary disorders     
Proteinuria † 1  64/323 (19.81%)  156 36/315 (11.43%)  60
Respiratory, thoracic and mediastinal disorders     
Cough † 1  25/323 (7.74%)  29 18/315 (5.71%)  18
Dyspnoea † 1  36/323 (11.15%)  49 21/315 (6.67%)  26
Epistaxis † 1  48/323 (14.86%)  76 14/315 (4.44%)  19
Hiccups † 1  36/323 (11.15%)  63 33/315 (10.48%)  46
Skin and subcutaneous tissue disorders     
Alopecia † 1  19/323 (5.88%)  21 16/315 (5.08%)  20
Dry skin † 1  20/323 (6.19%)  23 16/315 (5.08%)  17
Palmar-plantar erythrodysaesthesia syndrome † 1  99/323 (30.65%)  248 63/315 (20.00%)  121
Skin hyperpigmentation † 1  18/323 (5.57%)  18 10/315 (3.17%)  10
Vascular disorders     
Embolism venous † 1  13/323 (4.02%)  13 17/315 (5.40%)  17
Hypertension † 1  70/323 (21.67%)  152 23/315 (7.30%)  30
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 23.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02314117    
Other Study ID Numbers: 15372
I4T-MC-JVCU ( Other Identifier: Eli Lilly and Company )
2014-002240-40 ( EudraCT Number )
First Submitted: December 8, 2014
First Posted: December 10, 2014
Results First Submitted: March 30, 2018
Results First Posted: May 2, 2018
Last Update Posted: August 26, 2021