Trial · NCT01183780
A Study in Second Line Metastatic Colorectal Cancer
NCT01183780, Phase 3, Completed, Eli Lilly and Company; results first posted 2015-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Second Line Metastatic Colorectal Cancer. Trials, record NCT01183780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01183780
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Second Line Metastatic Colorectal Cancer
- NCT number
- NCT01183780
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,072 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Colorectal Cancer
- Interventions
- Ramucirumab, Placebo, Irinotecan, Folinic Acid, 5-Fluorouracil
- First posted
- 2010-08-18
- Last updated
- 2019-09-25
- Other registries' IDs
- eudract:2010-021037-32
- Results first posted
- 2015-07-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Randomization to Date of Death from Any Cause Up to 39.36 Months | OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive. |
| Secondary | Progression-free Survival (PFS) Time | Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months | PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) \[according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1\] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment. |
| Secondary | Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Randomization until Disease Progression Up to 38.01 Months | The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 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 at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status | Baseline Up to 171 Weeks | The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation was applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Maximum improvement is the best post-baseline change. |
| Secondary | Change From Baseline in EuroQol- 5D (EQ-5D) | Baseline and 30-Day Follow-Up (FU) up to 171 Weeks | The EQ-5D is a generic, multidimensional, health status instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale (no problem, some problems, and major problems). These combinations of attributes were converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). A negative change indicated a worsening of the participant's health status. |
| Secondary | Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Cycles 1, 3, 5, and 30-Day FU | Blood samples were tested to determine if a participant reacted to ramucirumab by producing anti-ramucirumab antibodies. Samples were identified as treatment emergent anti-drug antibody (TE ADA) if the post-treatment sample had an increase of at least 4 fold in titer from pre-treatment values. If the pre-treatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence. The percentage of participants with TE ADA was calculated as: (the number of participants with TE ADA / total number of participants with at least 1 post-treatment immunogenicity sample analyzed)\*100. |
| Secondary | Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab | Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17 |
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 | Overall Survival (OS) | Randomization to Date of Death from Any Cause Up to 39.36 Months | All randomized participants. Participants censored: Ramucirumab + FOLFIRI group = 164; Placebo + FOLFIRI= 139. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) Time | Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months | All randomized participants. Participants censored: Ramucirumab + FOLFIRI = 60; Placebo + FOLFIRI = 42. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Randomization until Disease Progression Up to 38.01 Months | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status | Baseline Up to 171 Weeks | All randomized participants who had EORTC QLQ-C30 assessed at baseline and post-baseline . | units on a scale | MEAN |
| SECONDARY | Change From Baseline in EuroQol- 5D (EQ-5D) | Baseline and 30-Day Follow-Up (FU) up to 171 Weeks | All randomized participants who had EQ-5D assessed at baseline and 30-day FU. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies | Cycles 1, 3, 5, and 30-Day FU | All participants who received study treatment and who had immunogenicity samples analyzed at the specified time points. | percentage of participants | NUMBER |
| SECONDARY | Observed Maximum Concentration (Cmax) and Observed Minimum Concentration (Cmin) of Ramucirumab | Preinfusion and 1 hour postinfusion in Cycles 3, 5, 9, 13, and 17 | All randomized participants who received at least one dose of study drug and had evaluable data for Cmin and Cmax. | micrograms/milliliter (ug/mL) | GEOMETRIC_MEAN |
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 |
|---|---|---|---|---|---|
| Overall Survival (OS) | Ramucirumab + FOLFIRI | 13.3 | 95% Confidence Interval 12.4 to 14.5 | months | |
| Overall Survival (OS) | Placebo + FOLFIRI | 11.7 | 95% Confidence Interval 10.8 to 12.7 | months | |
| Progression-free Survival (PFS) Time | Ramucirumab + FOLFIRI | 5.7 | 95% Confidence Interval 5.5 to 6.2 | months | |
| Progression-free Survival (PFS) Time | Placebo + FOLFIRI | 4.5 | 95% Confidence Interval 4.2 to 5.4 | months | |
| Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Ramucirumab + FOLFIRI | 13.4 | 95% Confidence Interval 10.7 to 16.6 | percentage of participants | |
| Percentage of Participants Achieving an Objective Response (Objective Response Rate) | Placebo + FOLFIRI | 12.5 | 95% Confidence Interval 9.8 to 15.6 | percentage of participants | |
| Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status | Ramucirumab + FOLFIRI | 4.0 | Standard Deviation 20.61 | units on a scale | |
| Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status | Placebo + FOLFIRI | 6.6 | Standard Deviation 18.84 | units on a scale | |
| Change From Baseline in EuroQol- 5D (EQ-5D) | Ramucirumab + FOLFIRI | -0.097 | Standard Deviation 0.279 | units on a scale | |
| Change From Baseline in EuroQol- 5D (EQ-5D) | Placebo + FOLFIRI | -0.103 | Standard Deviation 0.264 | units on a scale |
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 + FOLFIRI | 536 | |
| Overall Study | STARTED | Placebo + FOLFIRI | 536 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ramucirumab + FOLFIRI | 528 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo + FOLFIRI | 529 | |
| Overall Study | COMPLETED | Ramucirumab + FOLFIRI | 505 | |
| Overall Study | COMPLETED | Placebo + FOLFIRI | 511 | |
| Overall Study | NOT COMPLETED | Ramucirumab + FOLFIRI | 31 | |
| Overall Study | NOT COMPLETED | Placebo + FOLFIRI | 25 |
Source ClinicalTrials.gov
Adverse events610
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 | FOLFIRI + Ramucirumab | 93 | 529 | 225 |
| other | Anaemia | Blood and lymphatic system disorders | FOLFIRI + Placebo | 117 | 528 | 270 |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFIRI + Ramucirumab | 183 | 529 | 510 |
| other | Neutropenia | Blood and lymphatic system disorders | FOLFIRI + Placebo | 131 | 528 | 259 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFIRI + Ramucirumab | 80 | 529 | 177 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | FOLFIRI + Placebo | 42 | 528 | 82 |
| other | Abdominal distension | Gastrointestinal disorders | FOLFIRI + Ramucirumab | 22 | 529 | 26 |
| other | Abdominal distension | Gastrointestinal disorders | FOLFIRI + Placebo | 27 | 528 | 29 |
| other | Abdominal pain | Gastrointestinal disorders | FOLFIRI + Ramucirumab | 124 | 529 | 178 |
| other | Abdominal pain | Gastrointestinal disorders | FOLFIRI + Placebo | 123 | 528 | 181 |
1 to 10 of 610Source ClinicalTrials.gov
See all 610 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FOLFIRI + Ramucirumab | ||
| Total, all-cause mortality | FOLFIRI + Placebo | ||
| Total, other adverse events | FOLFIRI + Ramucirumab | 518 | 529 |
| Total, other adverse events | FOLFIRI + Placebo | 510 | 528 |
| Total, serious adverse events | FOLFIRI + Ramucirumab | 198 | 529 |
| Total, serious adverse events | FOLFIRI + Placebo | 175 | 528 |
Source ClinicalTrials.gov
Papers8
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 |
|---|
| FOLFIRI + Ramucirumab vs FOLFIRI + Placebo: 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/NCT01183780
GET https://conductscience.org/api/trials/v1/NCT01183780/results?page=2