Trial · NCT02539225
A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma
NCT02539225, Phase 2, Completed, Eli Lilly and Company; results first posted 2019-02-15
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma. Trials, record NCT02539225. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02539225
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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 or Gastroesophageal Junction Adenocarcinoma
- NCT number
- NCT02539225
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 191 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Interventions
- Ramucirumab, Placebo, S-1, Oxaliplatin, Paclitaxel
- First posted
- 2015-09-02
- Last updated
- 2022-03-08
- Results first posted
- 2019-02-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Randomization to Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months) | PFS is defined as the time from the date of randomization until the date of objectively determined progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause, whichever is first. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 millimeter (mm) or the appearance of ≥1 new lesions was progression. Participants who did not progress, were lost to follow-up were censored at the day of their last adequate tumor assessment. |
| Secondary | Progression-free Survival to the Second Disease Progression (PFS 2) | Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months) | Progression-free survival 2 (PFS2) is defined as the time from the date of randomization to second disease progression (defined as the date of first tumor assessment observing PD defined by RECIST v.1.1, after the start of second-line therapy using the last tumor assessment before starting the second-line therapy (RAM+PTX) as the baseline assessment), or death of any cause, whichever occurs first. If the second-line therapy was not started, the OS will be substituted for PFS2. If a post-discontinuation therapy was started before observing PD after the start of second-line therapy. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. PFS2 will be censored at the date of the last adequate tumor assessment on or before staring the post-discontinuation therapy. |
| Secondary | Overall Survival (OS) | Randomization to Death Due to Any Cause (Up to 31 Months) | Overall survival is defined as time from the date of randomization to the date of death from any cause. If the patient was alive at the cut-off for analysis (or lost to follow-up), OS data were censored for analysis on the last date the patient was known to be alive. |
| Secondary | Percentage of Participants With Objective Response Rate (ORR) | Randomization to Disease Progression (Up to 25 Months) | The ORR is the number of all participants with Partial Response (PR) or Complete Response (CR) according to RECIST v1.1 from the start of the treatment until disease progression/recurrence. CR is defined as the disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 mm. PR is defined as ≥30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression. |
| Secondary | Disease Control Rate (DCR) | Randomization to Disease Progression (Up to 25 Months) | Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Disease progression is defined as ≥20% increase in the sum of diameters of target lesions, taking as reference smallest sum on study (included baseline sum if that was the smallest on study); sum must have demonstrated an absolute increase of ≥5 mm or the appearance of ≥1 new lesions was progression. |
| Secondary | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A | Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 Predose | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A. |
| Secondary | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B | Cycle 1 Day 1 predose, Cycle 2 Day 1 predose | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B. |
| Secondary | Number of Participants With Anti-Ramucirumab Antibodies | Baseline through 25 months | Participant is considered as treatment emergent anti-drug antibody (TE ADA) positive if the participant has at least one post baseline titer that is a 4-fold or greater increase in titer from baseline measurement. If baseline result is ADA Not Present, then the participant is TE ADA+ if there is at least one post baseline result of ADA Present with titer \>= 20. |
Source ClinicalTrials.gov
Outcomes8
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 Radiographic Documentation of Progression or Death Due to Any Cause (Up to 25 Months) | All randomized participants who received any quantity of study drug in Part A. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 23; Placebo + S-1 + Oxaliplatin = 19. | Months | MEDIAN |
| SECONDARY | Progression-free Survival to the Second Disease Progression (PFS 2) | Randomization to Second Radiographic Documentation of Progression or Death Due to Any Cause (Up to 31 Months) | All randomized participants who received any quantity of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 26; Placebo + S-1 + Oxaliplatin = 26. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization to Death Due to Any Cause (Up to 31 Months) | All randomized participants who received at least one dose of study drug. Censored participants: Ramucirumab + S-1 + Oxaliplatin = 27; Placebo + S-1 + Oxaliplatin = 30. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Objective Response Rate (ORR) | Randomization to Disease Progression (Up to 25 Months) | All randomized participants who received any quantity of study drug in Part A with measurable disease. | percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) | Randomization to Disease Progression (Up to 25 Months) | All randomized participants who received any quantity of study drug in Part A with measurable disease. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part A | Cycle 1 Day 1 & 8 Predose, Cycle 2 Day 1 Predose, Cycle 3 Day 1 Predose, Cycle 5 Day 1 Predose, Cycle 9 Day 1 Predose | All randomized participants who received at least one dose of ramucirumab in part A and had evaluable PK samples. | Microgram per milliliter (ug/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Part B | Cycle 1 Day 1 predose, Cycle 2 Day 1 predose | All randomized participants who received at least one dose of ramucirumab in part B and had evaluable PK samples. | Microgram per milliliter (ug/mL) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Anti-Ramucirumab Antibodies | Baseline through 25 months | All randomized participants who received any quantity of study drug in part A and had at least one baseline \& post baseline antibody (ADA) measurement. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
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 + S-1 + Oxaliplatin | 6.34 | 80% Confidence Interval 5.65 to 6.93 | Months | |
| Progression Free Survival (PFS) | Placebo + S-1 + Oxaliplatin | 6.74 | 80% Confidence Interval 5.75 to 7.13 | Months | |
| Progression-free Survival to the Second Disease Progression (PFS 2) | Ramucirumab + S-1 + Oxaliplatin | 10.94 | 80% Confidence Interval 9.63 to 12.52 | Months | |
| Progression-free Survival to the Second Disease Progression (PFS 2) | Placebo + S-1 + Oxaliplatin | 11.99 | 80% Confidence Interval 9.82 to 13.83 | Months | |
| Overall Survival (OS) | Ramucirumab + S-1 + Oxaliplatin | 14.65 | 80% Confidence Interval 12.39 to 15.67 | Months | |
| Overall Survival (OS) | Placebo + S-1 + Oxaliplatin | 14.26 | 80% Confidence Interval 13.83 to 17.31 | Months | |
| Percentage of Participants With Objective Response Rate (ORR) | Ramucirumab + S-1 + Oxaliplatin | 58.2 | 80% Confidence Interval 49.7 to 66.7 | percentage of participants | |
| Percentage of Participants With Objective Response Rate (ORR) | Placebo + S-1 + Oxaliplatin | 50.0 | 80% Confidence Interval 41.3 to 58.7 | percentage of participants | |
| Disease Control Rate (DCR) | Ramucirumab + S-1 + Oxaliplatin | 90.9 | 80% Confidence Interval 85.9 to 95.9 | percentage of participants | |
| Disease Control Rate (DCR) | Placebo + S-1 + Oxaliplatin | 87 | 80% Confidence Interval 81.2 to 92.9 | percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Ramucirumab + S-1 + Oxaliplatin | 97 | |
| Part A | STARTED | Placebo + S-1 + Oxaliplatin | 94 | |
| Part A | Received Any Quantity of Study Drug | Ramucirumab + S-1 + Oxaliplatin | 96 | |
| Part A | Received Any Quantity of Study Drug | Placebo + S-1 + Oxaliplatin | 93 | |
| Part A | COMPLETED | Ramucirumab + S-1 + Oxaliplatin | 77 | |
| Part A | COMPLETED | Placebo + S-1 + Oxaliplatin | 78 | |
| Part A | NOT COMPLETED | Ramucirumab + S-1 + Oxaliplatin | 20 | |
| Part A | NOT COMPLETED | Placebo + S-1 + Oxaliplatin | 16 | |
| Pre Treatment for Part B | STARTED | Ramucirumab + S-1 + Oxaliplatin | 63 | |
| Pre Treatment for Part B | STARTED | Placebo + S-1 + Oxaliplatin | 66 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events2,012
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 + S-1 + Oxaliplatin - Part A | 25 | 96 | 37 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + S-1 + Oxaliplatin - Part A | 20 | 93 | 32 |
| other | Anaemia | Blood and lymphatic system disorders | Ramucirumab + S-1 + Oxaliplatin Part B | 15 | 58 | 19 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + S-1 + Oxaliplatin - Part B | 11 | 64 | 23 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Ramucirumab + S-1 + Oxaliplatin - Part A | 1 | 96 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Placebo + S-1 + Oxaliplatin - Part A | 1 | 93 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Ramucirumab + S-1 + Oxaliplatin Part B | 1 | 58 | 1 |
| other | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Placebo + S-1 + Oxaliplatin - Part B | 0 | 64 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Ramucirumab + S-1 + Oxaliplatin - Part A | 0 | 96 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo + S-1 + Oxaliplatin - Part A | 0 | 93 | 0 |
1 to 10 of 2,012Source ClinicalTrials.gov
See all 2,012 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab + S-1 + Oxaliplatin - Part A | 2 | 96 |
| Total, all-cause mortality | Placebo + S-1 + Oxaliplatin - Part A | 1 | 93 |
| Total, all-cause mortality | Ramucirumab + S-1 + Oxaliplatin Part B | 1 | 58 |
| Total, all-cause mortality | Placebo + S-1 + Oxaliplatin - Part B | 0 | 64 |
| Total, other adverse events | Ramucirumab + S-1 + Oxaliplatin - Part A | 95 | 96 |
| Total, other adverse events | Placebo + S-1 + Oxaliplatin - Part A | 93 | 93 |
| Total, other adverse events | Ramucirumab + S-1 + Oxaliplatin Part B | 58 | 58 |
| Total, other adverse events | Placebo + S-1 + Oxaliplatin - Part B | 64 | 64 |
| Total, serious adverse events | Ramucirumab + S-1 + Oxaliplatin - Part A | 29 | 96 |
| Total, serious adverse events | Placebo + S-1 + Oxaliplatin - Part A | 24 | 93 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31373648 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ramucirumab + S-1 + Oxaliplatin vs Placebo + S-1 + Oxaliplatin: Number of Participants With Anti-Ramucirumab Antibodies |
Source 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/NCT02539225
GET https://conductscience.org/api/trials/v1/NCT02539225/results?page=2