Trial · NCT01246960
A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer
NCT01246960, Phase 2, Completed, Eli Lilly and Company; results first posted 2014-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer. Trials, record NCT01246960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01246960
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ramucirumab in Participants With Gastric, Esophageal, and Gastroesophageal Cancer
- NCT number
- NCT01246960
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 168 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Stomach Cancer, Esophageal Cancer
- Interventions
- Ramucirumab, Placebo, Oxaliplatin, Leucovorin, 5-Fluorouracil
- First posted
- 2010-11-24
- Last updated
- 2014-10-08
- Results first posted
- 2014-10-08
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Randomization to measured PD or date of death from any cause (up to Month 25.0) | PFS was defined using Response Evaluation Criteria in Solid Tumors \[RECIST version (v.) 1.1\] as the time from randomization to the first observation of progressive disease (PD) or death due to any cause, whichever came first. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 millimeters (mm); the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. If a participant did not have a baseline disease assessment, PFS time was censored at the randomization date, regardless of whether or not PD or death was observed. Participants not known to have died or have objective PD were censored at the last post-baseline radiological assessment date. |
| Secondary | Overall Survival (OS) | Randomization to date of death from any cause (up to Month 28.3) | OS was defined as the time from randomization to death due to any cause. OS was censored at the date of the last follow-up visit for participants who were alive or lost to follow-up. |
| Secondary | Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Randomization to measured PD (up to Month 23.0) | The percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR) is reported. Response was defined using RECIST, v. 1.1 criteria. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. The percentage of participants with objective response=(number of participants whose best overall response achieved was CR or PR/number of participants treated)\*100. |
| Secondary | Duration of Response | Time of first response to measured PD (up to Month 23.0) | Duration of response was defined using RECIST v. 1.1 criteria as the time from the date criteria were met for the first objectively recorded CR or PR until the first date criteria for PD were met or death from any cause. CR was the disappearance of all lesions and pathological lymph node reduction in the short axis to \<10 mm. PR was a ≥30% decrease in the sum of the diameters of target lesions. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants who were not known to have died and who did not have PD were censored at the date of the last tumor assessment prior to the date of any subsequent systemic anticancer therapy. |
| Secondary | Time to Disease Progression (TTP) | Randomization to measured PD (up to Month 25.0) | TTP was defined using RECIST v. 1.1 as the time from study randomization to the first date of PD. PD was a ≥20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of ≥5 mm; the appearance of ≥1 new lesions or unequivocal progression of non-target lesions. TTP was censored at the date of last adequate tumor assessment if death was due to causes other than PD. |
| Secondary | Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Months 1, 2, 4, 6, and 8 | Participants with treatment-emergent anti-ramucirumab antibodies were participants with a 4-fold increase (2 dilution increase) in immunogenicity titer over baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). |
| Other | Number of Participants With Adverse Events (AEs) | Baseline through study completion (up to Month 28.3) | Reported are the number of participants who had ramucirumab/placebo-related: AEs, serious AEs (SAEs), AEs based on common terminology criteria for adverse events (CTCAE) ≥Grade 3, AEs = CTCAE Grade 5, as well as, AEs leading to treatment discontinuation and AEs resulting in death. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | Randomization to measured PD or date of death from any cause (up to Month 25.0) | ITT population: all randomized participants. Fourteen participants in the Ramucirumab and mFOLFOX6 treatment arm and 15 participants in the Placebo and mFOLFOX6 treatment arm were censored. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization to date of death from any cause (up to Month 28.3) | ITT population: all randomized participants. Twenty-seven participants in the Ramucirumab and mFOLFOX6 treatment arm and 32 participants in the Placebo and mFOLFOX6 treatment arm were censored. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Randomization to measured PD (up to Month 23.0) | ITT population: all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | Time of first response to measured PD (up to Month 23.0) | Randomized participants who achieved an objective response of CR or PR. Eight participants in the Ramucirumab and mFOLFOX6 treatment arm and 8 participants in the Placebo and mFOLFOX6 treatment arm were censored. | months | MEDIAN |
| SECONDARY | Time to Disease Progression (TTP) | Randomization to measured PD (up to Month 25.0) | ITT population: all randomized participants. Thirty-five participants in the Ramucirumab and mFOLFOX6 treatment arm and 31 participants in the Placebo and mFOLFOX6 treatment arm were censored. | months | MEDIAN |
| SECONDARY | Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Months 1, 2, 4, 6, and 8 | Randomized participants who received any quantity of ramucirumab or placebo, and were evaluated for the presence of anti-ramucirumab antibodies. | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Adverse Events (AEs) | Baseline through study completion (up to Month 28.3) | Safety population: randomized participants who received any quantity of study drug (Ramucirumab, mFOLFOX6, or placebo). | participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Ramucirumab and mFOLFOX6 | 6.4 | 95% Confidence Interval 5.8 to 9.3 | months | |
| Progression-Free Survival (PFS) | Placebo and mFOLFOX6 | 6.7 | 95% Confidence Interval 5.6 to 7.8 | months | |
| Overall Survival (OS) | Ramucirumab and mFOLFOX6 | 11.7 | 95% Confidence Interval 10.2 to 14.6 | months | |
| Overall Survival (OS) | Placebo and mFOLFOX6 | 11.5 | 95% Confidence Interval 9.0 to 15.3 | months | |
| Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Ramucirumab and mFOLFOX6 | 45.2 | 95% Confidence Interval 34.3 to 56.5 | percentage of participants | |
| Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Placebo and mFOLFOX6 | 46.4 | 95% Confidence Interval 35.5 to 57.6 | percentage of participants | |
| Duration of Response | Ramucirumab and mFOLFOX6 | 7.4 | 95% Confidence Interval 4.2 to 8.4 | months | |
| Duration of Response | Placebo and mFOLFOX6 | 5.8 | 95% Confidence Interval 4.4 to 8.0 | months | |
| Time to Disease Progression (TTP) | Ramucirumab and mFOLFOX6 | 8.7 | Full Range 6.0 to 9.8 | months | |
| Time to Disease Progression (TTP) | Placebo and mFOLFOX6 | 7.1 | Full Range 5.8 to 9.2 | months |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ramucirumab and mFOLFOX6 | 84 | |
| Overall Study | STARTED | Placebo and mFOLFOX6 | 84 | |
| Overall Study | Received Any Quantity of Study Drug | Ramucirumab and mFOLFOX6 | 82 | |
| Overall Study | Received Any Quantity of Study Drug | Placebo and mFOLFOX6 | 80 | |
| Overall Study | COMPLETED | Ramucirumab and mFOLFOX6 | 78 | |
| Overall Study | COMPLETED | Placebo and mFOLFOX6 | 80 | |
| Overall Study | NOT COMPLETED | Ramucirumab and mFOLFOX6 | 6 | |
| Overall Study | NOT COMPLETED | Placebo and mFOLFOX6 | 4 |
Source ClinicalTrials.gov
Adverse events364
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Ramucirumab and mFOLFOX6 | 29 | 82 | 41 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo and mFOLFOX6 | 38 | 80 | 58 |
| other | Leukopenia | Blood and lymphatic system disorders | Ramucirumab and mFOLFOX6 | 7 | 82 | 18 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo and mFOLFOX6 | 9 | 80 | 14 |
| other | Neutropenia | Blood and lymphatic system disorders | Ramucirumab and mFOLFOX6 | 29 | 82 | 76 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and mFOLFOX6 | 33 | 80 | 108 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ramucirumab and mFOLFOX6 | 30 | 82 | 62 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and mFOLFOX6 | 20 | 80 | 45 |
| other | Vision blurred | Eye disorders | Ramucirumab and mFOLFOX6 | 3 | 82 | 3 |
| other | Vision blurred | Eye disorders | Placebo and mFOLFOX6 | 6 | 80 | 7 |
1 to 10 of 364Source ClinicalTrials.gov
See all 364 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab and mFOLFOX6 | ||
| Total, all-cause mortality | Placebo and mFOLFOX6 | ||
| Total, other adverse events | Ramucirumab and mFOLFOX6 | 82 | 82 |
| Total, other adverse events | Placebo and mFOLFOX6 | 79 | 80 |
| Total, serious adverse events | Ramucirumab and mFOLFOX6 | 48 | 82 |
| Total, serious adverse events | Placebo and mFOLFOX6 | 32 | 80 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27765757 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramucirumab and mFOLFOX6 vs Placebo and mFOLFOX6: Number of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Trial comparisons |
| Ramucirumab and mFOLFOX6 vs Placebo and mFOLFOX6: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01246960
GET https://conductscience.org/api/trials/v1/NCT01246960/results?page=2