Trial · NCT02426125
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
NCT02426125, Phase 3, Completed, Eli Lilly and Company; results first posted 2019-03-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer. Trials, record NCT02426125. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02426125
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
- NCT number
- NCT02426125
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 530 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Urothelial Carcinoma
- Interventions
- Ramucirumab, Docetaxel, Placebo
- First posted
- 2015-04-24
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2014-003655-66
- Results first posted
- 2019-03-08
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months) | PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date. |
| Secondary | Overall Survival (OS) | Randomization to Date of Death from Any Cause (Up to 31.1 Months) | OS is the time from the date of randomization to the date of death from any cause. For each participant who is not known to have died as of the data inclusion cutoff date for a particular analysis, OS was censored for that analysis at the last known alive date prior to the data inclusion cutoff date. |
| Secondary | Percentage of Participants With an Objective Response Rate (ORR) | Randomization to Disease Progression (Up to 29.7 Months) | ORR is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 millimeter (mm). Tumor-marker results must have normalized. PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Best overall response is classified based on the overall responses assessed by study investigators according to RECIST v1.1. |
| Secondary | Percentage of Participants With Disease Control Rate (DCR) | Randomization to Disease Progression (Up to 29.7 Months) | DCR is the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). |
| Secondary | Duration of Response (DoR) | Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 28.4 Months) | Objective response was achieved if they had a best overall response of CR or PR. Target lesions- CR: Disappearance of all lesions; any pathological lymph nodes have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s). If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date, DOR was censored at the date of the last adequate tumor assessment. |
| Secondary | Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale | Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months) | Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment. Scores for global health status/QoL range from 0 to 100 with; higher scores representing better QoL. |
| Secondary | Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months) | The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Scores range from 0 (death) to 1 (perfect health), but scores \<0 are possible based on the algorithm. |
| Secondary | Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) | Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months) | The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. A unique EQ-5D health state is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a VAS ranging from 100 (best imaginable health state) to 0 (worst imaginable health state). |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab | Cycle 1 and Cycle 9, Day 1: Predose, Postdose | Cmax of Ramucirumab at the end of ramucirumab infusion. |
| Secondary | PK: Minimum Concentration (Cmin) of Ramucirumab | Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose) | Cmin of Ramucirumab following administration every 3 weeks. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Radiological Disease Progression or Death from Any Cause (Up to 18 Months) | The first randomized participants. Censored participants: Ramucirumab + Docetaxel = 58, Placebo + Docetaxel =38. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Randomization to Date of Death from Any Cause (Up to 31.1 Months) | All randomized participants. Censored participants: Ramucirumab + Docetaxel = 78, Placebo + Docetaxel = 67. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With an Objective Response Rate (ORR) | Randomization to Disease Progression (Up to 29.7 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control Rate (DCR) | Randomization to Disease Progression (Up to 29.7 Months) | All randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DoR) | Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up to 28.4 Months) | All randomized participants with CR or PR. Participants censored in Ramucirumab + Docetaxel = 12 and in Placebo + Docetaxel = 5. | Months | MEDIAN |
| SECONDARY | Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale | Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months) | All randomized participants. Censored participants: Ramucirumab + Docetaxel = 160, Placebo + Docetaxel = 173. | Months | MEDIAN |
| SECONDARY | Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score | Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months) | All randomized participants with baseline and 30-day follow-up data. | units on a scale | MEAN |
| SECONDARY | Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) | Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months) | All randomized participants with baseline and 30-day follow-up data. | millimeter (mm) | MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab | Cycle 1 and Cycle 9, Day 1: Predose, Postdose | All randomized participants who had evaluable PK data. | microgram/milliliter (μg/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Minimum Concentration (Cmin) of Ramucirumab | Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose) | All randomized participants who had evaluable PK data. | μg/mL | GEOMETRIC_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults 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 + Docetaxel | 4.07 | 95% Confidence Interval 2.96 to 4.47 | Months | |
| Progression Free Survival (PFS) | Placebo + Docetaxel | 2.76 | 95% Confidence Interval 2.60 to 2.96 | Months | |
| Overall Survival (OS) | Ramucirumab + Docetaxel | 9.40 | 95% Confidence Interval 7.89 to 11.43 | Months | |
| Overall Survival (OS) | Placebo + Docetaxel | 7.85 | 95% Confidence Interval 7.00 to 9.30 | Months | |
| Percentage of Participants With an Objective Response Rate (ORR) | Ramucirumab + Docetaxel | 25.9 | 95% Confidence Interval 20.6 to 31.1 | percentage of participants | |
| Percentage of Participants With an Objective Response Rate (ORR) | Placebo + Docetaxel | 13.9 | 95% Confidence Interval 9.7 to 18.0 | percentage of participants | |
| Percentage of Participants With Disease Control Rate (DCR) | Ramucirumab + Docetaxel | 65.4 | 95% Confidence Interval 59.7 to 71.1 | percentage of participants | |
| Percentage of Participants With Disease Control Rate (DCR) | Placebo + Docetaxel | 55.1 | 95% Confidence Interval 49.1 to 61.0 | percentage of participants | |
| Duration of Response (DoR) | Ramucirumab + Docetaxel | 5.32 | 95% Confidence Interval 3.94 to 6.87 | Months | |
| Duration of Response (DoR) | Placebo + Docetaxel | 4.17 | 95% Confidence Interval 3.29 to 5.55 | 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 + Docetaxel | 263 | |
| Overall Study | STARTED | Placebo + Docetaxel | 267 | |
| Overall Study | Received at Least One Dose of Study Drug | Ramucirumab + Docetaxel | 258 | |
| Overall Study | Received at Least One Dose of Study Drug | Placebo + Docetaxel | 265 | |
| Overall Study | COMPLETED | Ramucirumab + Docetaxel | 46 | |
| Overall Study | COMPLETED | Placebo + Docetaxel | 39 | |
| Overall Study | NOT COMPLETED | Ramucirumab + Docetaxel | 217 | |
| Overall Study | NOT COMPLETED | Placebo + Docetaxel | 228 |
Source ClinicalTrials.gov
Adverse events1,366
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 + Docetaxel | 50 | 258 | 87 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo+Docetaxel | 76 | 265 | 140 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Ramucirumab + Docetaxel | 1 | 258 | 1 |
| other | Blood loss anaemia | Blood and lymphatic system disorders | Placebo+Docetaxel | 0 | 265 | 0 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Ramucirumab + Docetaxel | 9 | 258 | 9 |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Placebo+Docetaxel | 5 | 265 | 5 |
| other | Leukocytosis | Blood and lymphatic system disorders | Ramucirumab + Docetaxel | 1 | 258 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo+Docetaxel | 3 | 265 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Ramucirumab + Docetaxel | 8 | 258 | 25 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo+Docetaxel | 5 | 265 | 9 |
1 to 10 of 1,366Source ClinicalTrials.gov
See all 1,366 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramucirumab + Docetaxel | 193 | 258 |
| Total, all-cause mortality | Placebo+Docetaxel | 209 | 265 |
| Total, other adverse events | Ramucirumab + Docetaxel | 241 | 258 |
| Total, other adverse events | Placebo+Docetaxel | 251 | 265 |
| Total, serious adverse events | Ramucirumab + Docetaxel | 111 | 258 |
| Total, serious adverse events | Placebo+Docetaxel | 107 | 265 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ramucirumab + Docetaxel vs Placebo + Docetaxel: Number of Participants With Anti-Ramucirumab Antibodies | Trial comparisons |
| Ramucirumab + Docetaxel vs Placebo+Docetaxel: deaths from any cause | Trial comparisons |
| Ramucirumab + Docetaxel vs Placebo+Docetaxel: 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/NCT02426125
GET https://conductscience.org/api/trials/v1/NCT02426125/results?page=2