NCT00917384 · STUDY IN CONTEXT
Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).
The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.
ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.
DOR is the interval from date of initial documented response (complete response \[CR\] or partial response \[PR\]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.
EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
Reported safety
Quality of life and patient-reported measures
EORTC QLQ · Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- qol key
- qol-0005
- source section id
- NCT00917384-om-0005
- source outcome index
- 5
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
- measure definition
- EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
- time frame
- Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represent a better
- population note
- All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- trial label
- Study of IMC-1121B (Ramucirumab) With Best Supportive Care in Participants With Gastric Cancer and Adenocarcinoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 1
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0000
- source section id
- NCT00917384-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival (OS)
- endpoint definition
- Overall survival is defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the date of data cut-off or who were lost to follow-up were censored on the last date the participant was known to be alive
- time origin
- Randomization up to 28 months post-randomization
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=59, placebo=18.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0001
- source section id
- NCT00917384-om-0001
- source outcome index
- 1
- endpoint
- Progression-Free Survival (PFS)
- endpoint definition
- PFS is defined as the time from date of randomization until date of objectively determined progressive disease (PD) or death due to any cause, whichever is first. Participants alive and without PD were censored at the time of last adequate objective tumor assessment (that is, response other than unevaluable).
- time origin
- Randomization up to 17 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat population: all randomized participants. Censored participants: ramucirumab=39, placebo=9.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0002
- source section id
- NCT00917384-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
- endpoint definition
- The percentage of participants alive and progression-free 12 weeks after randomization. Progression-free survival (PFS) is defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) or death due to any cause whichever comes first. Participants alive and without PD were censored at the time of the last adequate objective tumor assessment.
- time origin
- Week 12 post-randomization
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat population: all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0003
- source section id
- NCT00917384-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants With Objective Response (Objective Response Rate [ORR])
- endpoint definition
- ORR is equal to the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR). CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment.
- time origin
- Randomization up to 17 months post-randomization
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Intent-to-treat population: all randomized participants.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0004
- source section id
- NCT00917384-om-0004
- source outcome index
- 4
- endpoint
- Duration of Response (DOR)
- endpoint definition
- DOR is the interval from date of initial documented response (complete response \[CR\] or partial response \[PR\]) to first documented date of disease progression (PD) or death as a result of any cause. CR and PR were defined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR is defined as the disappearance of all target and non-target lesions, no appearance of new lesions and confirmed at the consecutive tumor assessment. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, no appearance of new lesions and confirmed at a subsequent tumor assessment. Participants who did not relapse or die were censored at the time of the last adequate objective tumor assessment.
- time origin
- Randomization up to 17 months post-randomization
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Zero participants were analyzed. The number of all responders (participants with CR or PR) was too small for a meaningful analysis, as specified in the statistical analysis plan.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0005
- source section id
- NCT00917384-om-0005
- source outcome index
- 5
- endpoint
- Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
- endpoint definition
- EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
- time origin
- Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0000
- arm key
- OG000
- arm label
- IMC-1121B (Ramucirumab)
- regimen
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 238
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0001
- arm key
- OG000
- arm label
- IMC-1121B (Ramucirumab)
- regimen
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 238
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0002
- arm key
- OG000
- arm label
- IMC-1121B (Ramucirumab)
- regimen
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 238
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0003
- arm key
- OG000
- arm label
- IMC-1121B (Ramucirumab)
- regimen
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 238
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 117
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0004
- arm key
- OG000
- arm label
- IMC-1121B (Ramucirumab)
- regimen
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0005
- arm key
- OG000
- arm label
- IMC-1121B (Ramucirumab)
- regimen
- Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 114
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Placebo
- regimen
- Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
- analyzed count
- 26
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00917384-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- harm key
- EG000
- source section id
- NCT00917384-ae
- event group key
- EG000
- event group label
- IMC-1121B (Ramucirumab)
- serious affected
- 112
- serious at risk
- 236
- other affected
- 213
- other at risk
- 236
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- harm key
- EG001
- source section id
- NCT00917384-ae
- event group key
- EG001
- event group label
- Placebo
- serious affected
- 51
- serious at risk
- 115
- other affected
- 91
- other at risk
- 115
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-gastric-cancer
- nct id
- NCT00917384
- qol key
- qol-0005
- source section id
- NCT00917384-om-0005
- source outcome index
- 5
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
- measure definition
- EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms. Best change from baseline results determined by Least Square (LS) mean estimated with randomization stratification factors and baseline value as continuous covariate.
- time frame
- Baseline up to Cycle 10 (18 weeks [1 cycle=2 weeks])
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher scores represent a better
- population note
- All randomized participants with EORTC QLQ-C30 values at baseline and any point up to 18 weeks post-baseline.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice
Triangle