A Phase 3 interventional study of ramucirumab and Placebo in Gastric Cancer and Adenocarcinoma, sponsored by Eli Lilly and Company. Completed at 161 sites in 30 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The purpose of this study is to gather information about the use of an investigational drug called Ramucirumab in adenocarcinomas of the stomach or gastroesophageal junction.
Placebo-controlled, multicenter Phase 3 study of participants with metastatic gastric cancer [including adenocarcinomas of the gastroesophageal junction (GEJ)] and disease progression on standard first-line chemotherapeutic regimens. Participants will be randomized on a 2:1 basis to receive best supportive care plus ramucirumab administered every 2 weeks or best supportive care plus placebo administered every 2 weeks, respectively. Participants will undergo radiographic assessment of disease status every 6 weeks. Participant will be treated until there is evidence of progressive disease, toxicity requiring cessation, withdrawal of consent, or until other withdrawal criteria are met.
Approximately 348 participants, with histologically- or cytologically-confirmed, metastatic gastric or GEJ adenocarcinoma, and radiographically measurable disease as defined by the Response Evaluation Criteria in Solid Tumors or evaluable, nonmeasurable disease, will be randomized. Participants will be enrolled from approximately 250 study centers in North America, South America, Central America, Asia, Australia, New Zealand, and Europe.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's enrollment of 355 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Examples of evaluable, nonmeasurable disease include gastric, peritoneal, or mesenteric thickening in areas of known disease, or peritoneal nodules that are too small to be considered measurable by RECIST
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive ramucirumab, administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), and best supportive care (BSC) as determined appropriate by the investigator(s). Treatment will continue until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Biological: ramucirumab · Other: Best Supportive Care (BSC)
Participants receive injection for intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel will be blinded as to assignment to active therapy versus placebo, the volume of placebo to be administered will be calculated as if it were active product with a dose of 8 mg/kg. Treatment will continue until there is evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
Drug: Placebo · Other: Best Supportive Care (BSC)
Administered via intravenous infusion every 2 weeks at a dose of 8 mg/kg
Also known as: IMC-1121B, LY3009806
Placebo comparator for ramucirumab 8 mg/kg as intravenous infusion every 2 weeks
BSC as determined appropriate by the investigator(s). BSC may include but are not limited to antiemetic agents, opiate and nonopiate analgesic agents, appetite stimulants, and granulocyte and erythroid growth factors.
Overall Survival (OS)
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 frame: Randomization up to 28 months post-randomization
Progression-Free Survival (PFS)
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 frame: Randomization up to 17 months
Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate)
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 frame: Week 12 post-randomization
Percentage of Participants With Objective Response (Objective Response Rate [ORR])
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 frame: Randomization up to 17 months post-randomization
Duration of Response (DOR)
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 frame: Randomization up to 17 months post-randomization
Change From Baseline in Quality of Life (QoL) as Measured by the European Organisation for Research and Treatment of Cancer Questionnaire (EORTC-QLQ-C30)
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])
Number of Participants With Adverse Events
Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.
Time frame: Randomization up to 18 months
Maximum Concentration (Cmax) of IMC-1121B
Cmax was not analyzed as only pre-dose samples were collected.
Time frame: 6 weeks post-randomization
Number of Participants Who Developed Antibodies Against IMC-1121B
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
Time frame: Baseline, 12 Weeks
| Milestone | IMC-1121B (Ramucirumab ) | Placebo |
|---|---|---|
| Started | 238 | 117 |
| Received at least 1 dose of study drug | 236 | 115 |
| Completed | 224 | 113 |
| Not completed | 14 | 4 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Withdrawal by subject | 10 | 2 |
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
| months | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Overall Survival (OS) | 5.2 (4.4 to 5.7) | 3.8 (2.8 to 4.7) |
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).
| months | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Progression-Free Survival (PFS) | 2.1 (1.5 to 2.7) | 1.3 (1.3 to 1.4) |
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.
| percentage of participants | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Percentage of Participants Who Are Progression-Free at Week 12 (PFS Rate) | 40.1 (33.6 to 46.4) | 15.8 (9.7 to 23.3) |
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.
| percentage of participants | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Percentage of Participants With Objective Response (Objective Response Rate [ORR]) | 3.4 (1.5 to 6.5) | 2.6 (0.5 to 7.3) |
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.
No measurements were reported for this outcome.
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.
| units on a scale | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Global Health Status/QoL | 2.42 ± 2.99 | 0.80 ± 4.48 |
| Physical Functioning | -6.26 ± 3.20 | -12.01 ± 4.82 |
| Role Functioning | -4.32 ± 4.65 | -11.79 ± 6.99 |
| Emotional Functioning | -1.61 ± 3.29 | -6.51 ± 4.92 |
| Cognitive Functioning | -4.26 ± 2.63 | -10.94 ± 3.94 |
| Social Functioning | -1.98 ± 3.90 | -1.37 ± 5.86 |
| Fatigue | 3.16 ± 3.43 | 6.88 ± 5.16 |
| Nausea and Vomiting | 1.77 ± 2.86 | 2.88 ± 4.32 |
| Pain | 0.13 ± 3.61 | 3.85 ± 5.42 |
| Dyspnea | -2.61 ± 3.35 | 3.51 ± 5.08 |
| Insomnia | -7.47 ± 4.19 | -3.95 ± 6.28 |
| Appetite Loss | -1.01 ± 4.60 | 7.16 ± 6.91 |
| Constipation | 0.09 ± 3.79 | 7.94 ± 5.69 |
| Diarrhea | -3.97 ± 1.64 | -5.49 ± 2.46 |
| Financial Difficulties | -12.86 ± 3.78 | -2.39 ± 5.68 |
Clinically significant events were defined as serious adverse events (SAE) and other treatment-emergent non-serious adverse events (NSAE). A summary of SAEs and all other NSAEs is located in the Reported Adverse Event module.
| participants | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Participants with SAE | 112 | 51 |
| Participants with ≥ 1 treatment emergent NSAE | 213 | 91 |
Cmax was not analyzed as only pre-dose samples were collected.
No measurements were reported for this outcome.
The number of participants who developed treatment emergent antibody responses to IMC-1121B after baseline.
| participants | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Number of Participants Who Developed Antibodies Against IMC-1121B | 6 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| IMC-1121B (Ramucirumab) | — | 112/236 (47.5%) | 213/236 (90.3%) |
| Placebo | — | 51/115 (44.3%) | 91/115 (79.1%) |
| Event | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| Disease progressionGeneral disorders | 10/236 | 8/115 |
| AnaemiaBlood and lymphatic system disorders | 11/236 | 2/115 |
| VomitingGastrointestinal disorders | 7/236 | 5/115 |
| Abdominal painGastrointestinal disorders | 10/236 | 3/115 |
| AstheniaGeneral disorders | 0/236 | 4/115 |
| Medication errorInjury, poisoning and procedural complications | 7/236 | 1/115 |
| AscitesGastrointestinal disorders | 6/236 | 3/115 |
| DysphagiaGastrointestinal disorders | 6/236 | 3/115 |
| DehydrationMetabolism and nutrition disorders | 4/236 | 3/115 |
| Malignant neoplasm progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/236 | 3/115 |
| Event | IMC-1121B (Ramucirumab) | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 45/236 | 30/115 |
| FatigueGeneral disorders | 58/236 | 28/115 |
| Decreased appetiteMetabolism and nutrition disorders | 55/236 | 26/115 |
| Abdominal painGastrointestinal disorders | 40/236 | 26/115 |
| VomitingGastrointestinal disorders | 45/236 | 26/115 |
| ConstipationGastrointestinal disorders | 37/236 | 24/115 |
| DiarrhoeaGastrointestinal disorders | 35/236 | 9/115 |
| HypertensionVascular disorders | 35/236 | 9/115 |
| AnaemiaBlood and lymphatic system disorders | 33/236 | 16/115 |
| AstheniaGeneral disorders | 30/236 | 16/115 |
All randomized participants.
| Age, Continuous(years) | IMC-1121B (Ramucirumab) | Placebo | Total |
|---|---|---|---|
| Median | 60.0 (30 to 86) | 60.0 (24 to 87) | 60.0 (24 to 87) |
| Sex: Female, Male(Participants) | IMC-1121B (Ramucirumab) | Placebo | Total |
|---|---|---|---|
| Female | 69 | 38 | 107 |
| Male | 169 | 79 | 248 |
| Ethnicity (NIH/OMB)(Participants) | IMC-1121B (Ramucirumab) | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 41 | 19 | 60 |
| Not Hispanic or Latino | 197 | 98 | 295 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | IMC-1121B (Ramucirumab) | Placebo | Total |
|---|---|---|---|
| Argentina | 4 | 2 | 6 |
| Australia | 8 | 4 | 12 |
| Bosnia and Herzegovina | 1 | 3 | 4 |
| Brazil | 24 | 14 | 38 |
| Canada | 8 | 2 | 10 |
| Chile | 1 | 1 | 2 |
| Colombia | 2 | 1 | 3 |
| Czech Republic | 24 | 13 | 37 |
| Egypt | 1 | 0 | 1 |
| Spain | 12 | 4 | 16 |
| United Kingdom | 13 | 4 | 17 |
| Guatemala | 6 | 2 | 8 |
| Croatia | 7 | 0 | 7 |
| Indonesia | 2 | 1 | 3 |
| India | 16 | 8 | 24 |
| Italy | 23 | 11 | 34 |
| Korea, Republic of | 11 | 6 | 17 |
| Lebanon | 1 | 0 | 1 |
| Malta | 2 | 3 | 5 |
| New Zealand | 1 | 1 | 2 |
| Philippines | 1 | 1 | 2 |
| Poland | 9 | 4 | 13 |
| Romania | 13 | 4 | 17 |
| Russian Federation | 14 | 8 | 22 |
| Thailand | 1 | 0 | 1 |
| Turkey | 5 | 1 | 6 |
| Taiwan | 3 | 0 | 3 |
| United States | 25 | 18 | 43 |
| South Africa | 0 | 1 | 1 |
| Race(participants) | IMC-1121B (Ramucirumab) | Placebo | Total |
|---|---|---|---|
| White | 181 | 91 | 272 |
| Asian | 39 | 17 | 56 |
| Black | 4 | 2 | 6 |
| Other | 14 | 7 | 21 |
Showing the first 100 of 161 sites across 30 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
The record gives a start of Aug 2009, a primary completion of Jul 2012 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2014, 2 years 3 months after primary completion. A results delay was requested in Jul 2010.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ramucirumab