Trial · NCT01170663
A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
NCT01170663, Phase 3, Completed, Eli Lilly and Company; results first posted 2014-07-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma. Trials, record NCT01170663. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01170663
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
- NCT number
- NCT01170663
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 665 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Gastric Cancer
- Interventions
- Ramucirumab (IMC-1211B) DP, Placebo, Paclitaxel
- First posted
- 2010-07-27
- Last updated
- 2019-09-18
- Other registries' IDs
- eudract:2010-020426-18
- Results first posted
- 2014-07-31
- Limitations and caveats
One (1) participant was randomized to the placebo/paclitaxel group but received ramucirumab in error. For ITT population this participant was included in placebo/paclitaxel group and for the Safety population included in the ramucirumab group.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival Time (OS) | Randomization up to 27.5 months | OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive. |
| Secondary | Progression-Free Survival (PFS) | Randomization up to 22.2 months | PFS was measured from date of randomization to first radiographically documented progressive disease (PD) or death due to any cause. PD defined using Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of at least 5 mm. Participants who had no baseline or post baseline radiological tumor assessment were censored at date of randomization. Participants who had no tumor progression or death within 2 scan intervals following the last assessment were censored at the date of last radiographic tumor assessment. Participants who began new anticancer treatment and had no tumor progression were censored at date of assessment prior to initiation of new therapy. Participants lost to follow-up or withdrew consent were censored at the date of their last assessment. |
| Secondary | Time to Progressive Disease (TTP) | Baseline up to 22.2 months | TTP was defined as the time from randomization until date of radiographic progression using RECIST v1.1 criteria. PD was defined as having a ≥20% increase in sum of longest diameter (LD) of target lesions and at minimum 5 millimeters (mm) increase above nadir. Participants who did not progress or were lost to follow-up were censored at the date of last tumor assessment. Participants who had no baseline tumor assessment or no post baseline assessment and no death reported with 2 scan intervals post randomization were censored at date of randomization. Participants with no progression and not died within 2 scan intervals after last assessment were censored at date of last tumor assessment. Participants with no post baseline assessment or tumor progression but death reported within 2 scan intervals after randomization were censored at date of death. |
| Secondary | Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | Randomization up to 22.2 months | BOR was defined as the best response across all time points from randomization until radiologically confirmed PD using RECIST, v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. PD was defined as having a ≥20% increase in sum of LD of target lesions and ≥5 mm increase above nadir. SD was defined as small changes that did not meet above criteria. |
| Secondary | Percentage of Participants With CR or PR (Objective Response Rate [ORR]) | Randomization up to 22.2 months | ORR was the percentage of participants who had CR or PR defined using RECIST v1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm and normalization of tumor marker level of non-target lesions. PR was defined as having a ≥30% decrease in sum of LD of target lesions. Percentage of participants calculated as: (number of participants with CR + PR)/(total number of participants)\*100. |
| Secondary | Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity) | Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks | Participants who developed treatment-emergent antibody responses to Ramucirumab (IMC-1121B) after baseline. |
| Secondary | Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion | Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles) | |
| Secondary | Cmax After 4th Ramucirumab (IMC-1211B) Infusion | Cycle 2, Day 15 1 hour post end of infusion (28-day cycles) | |
| Secondary | Cmax After 7th Ramucirumab (IMC-1211B) Infusion | Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles) | |
| Secondary | Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion | Cycle 1, Day 1 predose (28-day cycles) | This outcome measure was included in error as the time point was before ramucirumab (IMC-1211B) was administered. Cmin was not analyzed. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival Time (OS) | Randomization up to 27.5 months | All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =74, Placebo plus Paclitaxel =75. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | Randomization up to 22.2 months | All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =51, Placebo plus Paclitaxel =39. | months | MEDIAN |
| SECONDARY | Time to Progressive Disease (TTP) | Baseline up to 22.2 months | All participants according to the treatment group to which they were randomized. Participants censored: Ramucirumab (IMC-1211B) plus Paclitaxel =107, Placebo plus Paclitaxel =94. | months | MEDIAN |
| SECONDARY | Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | Randomization up to 22.2 months | All participants according to the treatment group to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With CR or PR (Objective Response Rate [ORR]) | Randomization up to 22.2 months | All participants according to the treatment group to which they were randomized. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Anti-Ramucirumab Antibodies (Serum Anti-Ramucirumab Antibody Assessment )(Immunogenicity) | Prior to and after ramucirumab (IMC-1121B) infusion: Day 1 Cycles 1, 2 and 3 (28-day cycles) Doses 1, 4, 7 and 30-37 days after last dose of study therapy up to 103 weeks | All participants according to the treatment group to which they were randomized and received at least 1 dose of study drug with anti-ramucirumab antibodies. | percentage of participants | NUMBER |
| SECONDARY | Maximum Concentration (Cmax) After First Ramucirumab (IMC-1211B) Infusion | Cycle 1, Day 1, 1 hour post end of infusion (28-day cycles) | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint. | micrograms/milliliter (µg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Cmax After 4th Ramucirumab (IMC-1211B) Infusion | Cycle 2, Day 15 1 hour post end of infusion (28-day cycles) | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Cmax After 7th Ramucirumab (IMC-1211B) Infusion | Cycle 4, Day 1, 1 hour post end of infusion (28-day cycles) | All participants who received Ramucirumab (IMC-1121B) plus Paclitaxel and had Cmax observations at specific timepoint. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Minimum Concentration (Cmin) Prior to First Ramucirumab (IMC-1211B) Infusion | Cycle 1, Day 1 predose (28-day cycles) | Zero participants were analyzed. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival Time (OS) | Ramucirumab (IMC-1211B) Plus Paclitaxel | 9.6 | 95% Confidence Interval 8.5 to 10.8 | months | |
| Overall Survival Time (OS) | Placebo Plus Paclitaxel | 7.4 | 95% Confidence Interval 6.3 to 8.4 | months | |
| Progression-Free Survival (PFS) | Ramucirumab (IMC-1211B) Plus Paclitaxel | 4.4 | 95% Confidence Interval 4.2 to 5.3 | months | |
| Progression-Free Survival (PFS) | Placebo Plus Paclitaxel | 2.9 | 95% Confidence Interval 2.8 to 3.0 | months | |
| Time to Progressive Disease (TTP) | Ramucirumab (IMC-1211B) Plus Paclitaxel | 5.52 | 95% Confidence Interval 4.50 to 5.68 | months | |
| Time to Progressive Disease (TTP) | Placebo Plus Paclitaxel | 3.02 | 95% Confidence Interval 2.86 to 4.14 | months | |
| Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | Ramucirumab (IMC-1211B) Plus Paclitaxel | CR | 0.6 | percentage of participants | |
| Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | Placebo Plus Paclitaxel | CR | 0.3 | percentage of participants | |
| Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | Ramucirumab (IMC-1211B) Plus Paclitaxel | PR | 27.3 | percentage of participants | |
| Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or PD | Placebo Plus Paclitaxel | PR | 15.8 | percentage of participants |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 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 (IMC-1211B) Plus Paclitaxel | 330 | |
| Overall Study | STARTED | Placebo Plus Paclitaxel | 335 | |
| Overall Study | Received Any Treatment (Safety Pop) | Ramucirumab (IMC-1211B) Plus Paclitaxel | 327 | |
| Overall Study | Received Any Treatment (Safety Pop) | Placebo Plus Paclitaxel | 329 | |
| Overall Study | COMPLETED | Ramucirumab (IMC-1211B) Plus Paclitaxel | 316 | |
| Overall Study | COMPLETED | Placebo Plus Paclitaxel | 315 | |
| Overall Study | NOT COMPLETED | Ramucirumab (IMC-1211B) Plus Paclitaxel | 14 | |
| Overall Study | NOT COMPLETED | Placebo Plus Paclitaxel | 20 |
Source ClinicalTrials.gov
Adverse events466
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 Paclitaxel | 110 | 327 | 261 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo and Paclitaxel | 116 | 329 | 274 |
| other | Leukopenia | Blood and lymphatic system disorders | Ramucirumab and Paclitaxel | 111 | 327 | 471 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo and Paclitaxel | 69 | 329 | 199 |
| other | Neutropenia | Blood and lymphatic system disorders | Ramucirumab and Paclitaxel | 174 | 327 | 878 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo and Paclitaxel | 102 | 329 | 247 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ramucirumab and Paclitaxel | 43 | 327 | 103 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo and Paclitaxel | 20 | 329 | 37 |
| other | Abdominal distension | Gastrointestinal disorders | Ramucirumab and Paclitaxel | 20 | 327 | 27 |
| other | Abdominal distension | Gastrointestinal disorders | Placebo and Paclitaxel | 20 | 329 | 25 |
1 to 10 of 466Source ClinicalTrials.gov
See all 466 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab and Paclitaxel | ||
| Total, all-cause mortality | Placebo and Paclitaxel | ||
| Total, other adverse events | Ramucirumab and Paclitaxel | 324 | 327 |
| Total, other adverse events | Placebo and Paclitaxel | 321 | 329 |
| Total, serious adverse events | Ramucirumab and Paclitaxel | 161 | 327 |
| Total, serious adverse events | Placebo and Paclitaxel | 146 | 329 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
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 and Paclitaxel vs Placebo and Paclitaxel: serious adverse events |
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/NCT01170663
GET https://conductscience.org/api/trials/v1/NCT01170663/results?page=2