Trial · NCT01282463
Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
NCT01282463, Phase 2, Completed, Eli Lilly and Company; results first posted 2019-07-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma. Trials, record NCT01282463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01282463
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ramucirumab or Icrucumab (IMC-18F1) With Docetaxel or Docetaxel Alone as Second-Line Therapy in Participants With Bladder,Urethra, Ureter, or Renal Pelvis Carcinoma
- NCT number
- NCT01282463
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Carcinoma of Urinary Tract, Urethral Carcinoma, Carcinoma of Ureter, Carcinoma of Renal Pelvis
- Interventions
- Docetaxel, Ramucirumab DP, Icrucumab
- First posted
- 2011-01-25
- Last updated
- 2019-09-09
- Results first posted
- 2019-07-02
Source ClinicalTrials.gov
Registered outcomes15
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 Death From Any Cause (Up To 40 Months) | PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization. |
| Secondary | Percentage of Participants Achieving Objective Response Rate (ORR) | Randomization to Measured PD (Up to 40 Months) | Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to \<10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels \[if tumor markers were initially above the upper limit of normal (ULN)\]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)\*100. |
| Secondary | Duration of Response | First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months) | The duration of response was measured from the time measurement criteria were first met for a CR or PR (whichever was first recorded) until the first date of objectively documented progressive disease (taking as a reference for progressive disease the smallest measurement recorded since randomization) or the date of death, whichever occurred first. Data for participants who did not relapse or die were censored at the day of their last adequate tumor assessment. Duration of response was estimated by the Kaplan-Meier method. |
| Secondary | Number of Participants With Adverse Events (AEs) | Up To 41.7 Months | A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section. |
| Secondary | Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab | Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI | |
| Secondary | PK: Minimum Concentration (Cmin) Ramucirumab | Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI | |
| Secondary | PK: Cmax Icrucumab | Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI | |
| Secondary | PK: Cmin Icrucumab | Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI | |
| Secondary | Number of Participants With Serum Anti-Ramucirumab Antibody Assessment | Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOI | Number of participants with at least one positive titer treatment emergent antibody positive neutralizing antibody detecting. A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals. |
| Secondary | Number of Participants With Serum Anti-Icrucumab Antibody Assessment | Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose | A sample will be considered positive for anti-Icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-IMC-Icrucumab antibody level seen in healthy untreated individuals. |
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 | Progression-Free Survival (PFS) | Randomization to Measured PD or Death From Any Cause (Up To 40 Months) | All randomized participants who received at least one dose of study drug. Participants censored: docetaxel arm = 40; docetaxel and ramucirumab arm = 34; docetaxel and Icrucumab arm = 41. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving Objective Response Rate (ORR) | Randomization to Measured PD (Up to 40 Months) | All randomized participants who received one dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response | First Criteria Met for CR or PR to Measured PD or Death From Any Cause (Up to 40 Months) | All randomized participants received one dose of study drug and had CR or PR. | months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up To 41.7 Months | All randomized participants who received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetics (PK) Maximum Concentration (Cmax) Ramucirumab | Cycle 1:Predose,1 hour(hr) post End of Infusion (EOI),48hr,72hr,168hr,336hr post-EOI;Cycle2:Predose,1hr post-EOI; Cycle3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI; Cycle4:Predose,1hr post-EOI;Cycle6 and every other cycle thereafter:Predose,1hr Post EOI | All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm. | microgram/milliliter (ug/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Minimum Concentration (Cmin) Ramucirumab | Cycle 2:Predose,1hr post-EOI;Cycle3:Predose,1hr,48hr,72hr,168hr,336hr, post-EOI;Cycle4:Predose,1hr post-EOI;Cycle6:Predose,1hr Post EOI | All randomized participants who received at least one dose of study drug and had evaluable PK data for Ramucirumab and there was no PK data for Docetaxel arm. | microgram/milliliter (ug/mL) | GEOMETRIC_MEAN |
| SECONDARY | PK: Cmax Icrucumab | Cycle 1:Predose,1 hr post-EOI, 48hr, 72hr Post-EOI; Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI | All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | PK: Cmin Icrucumab | Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,EOI,1.5hr,24hr,48hr,72hr,168hr Post EOI | All randomized participants who received at least one dose of study drug and had evaluable PK data for Icrucumab and there was no PK data for Docetaxel arm. | ug/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Serum Anti-Ramucirumab Antibody Assessment | Cycle 1:Predose,EOI,1hr,48hr,72hr,168hr,336 hr post-EOI:Cycle 2:Predose,1hr post-EOI;Cycle 3:Predose,1hr,48hr,72hr,168hr,336hr post-EOI;Cycle 4:Predose,1hr post-EOI;Cycle 6:Predose,1hr post-EOI | All randomized participants who received at least one dose of study drug and had baseline and post baseline anti-ramucirumab antibodies. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serum Anti-Icrucumab Antibody Assessment | Cycle 1 Day 1 and Day 8 Predose and 1hr Post Dose | Zero participants analyzed. Data not collected. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group29
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) | Docetaxel | 2.8 | 95% Confidence Interval 1.9 to 3.6 | months | |
| Progression-Free Survival (PFS) | Docetaxel + Ramucirumab DP | 5.4 | 95% Confidence Interval 3.1 to 6.9 | months | |
| Progression-Free Survival (PFS) | Docetaxel + Icrucumab | 1.6 | 95% Confidence Interval 1.4 to 5.4 | months | |
| Percentage of Participants Achieving Objective Response Rate (ORR) | Docetaxel | 8.9 | 95% Confidence Interval 2.5 to 21.2 | percentage of participants | |
| Percentage of Participants Achieving Objective Response Rate (ORR) | Docetaxel + Ramucirumab DP | 23.9 | 95% Confidence Interval 12.6 to 38.8 | percentage of participants | |
| Percentage of Participants Achieving Objective Response Rate (ORR) | Docetaxel + Icrucumab | 12.2 | 95% Confidence Interval 4.6 to 24.8 | percentage of participants | |
| Duration of Response | Docetaxel | 4.6 | 95% Confidence Interval 2.6 to 5.6 | months | |
| Duration of Response | Docetaxel + Ramucirumab DP | 4.6 | 95% Confidence Interval 0.7 to 7.0 | months | |
| Duration of Response | Docetaxel + Icrucumab | NA | 95% Confidence Interval 2.9 to NA | months | |
| Number of Participants With Adverse Events (AEs) | Docetaxel | Any AE | 45 | Participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Docetaxel | 49 | |
| Overall Study | STARTED | Docetaxel + Ramucirumab DP | 49 | |
| Overall Study | STARTED | Docetaxel + Icrucumab | 50 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Docetaxel | 45 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Docetaxel + Ramucirumab DP | 46 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Docetaxel + Icrucumab | 49 | |
| Overall Study | COMPLETED | Docetaxel | 41 | |
| Overall Study | COMPLETED | Docetaxel + Ramucirumab DP | 45 | |
| Overall Study | COMPLETED | Docetaxel + Icrucumab | 46 | |
| Overall Study | NOT COMPLETED | Docetaxel | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events555
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 | Docetaxel | 10 | 45 | 14 |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel + Ramucirumab DP | 11 | 46 | 44 |
| other | Anaemia | Blood and lymphatic system disorders | Docetaxel + Icrucumab | 20 | 49 | 49 |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel | 2 | 45 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel + Ramucirumab DP | 2 | 46 | 2 |
| other | Leukopenia | Blood and lymphatic system disorders | Docetaxel + Icrucumab | 5 | 49 | 14 |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel | 11 | 45 | 18 |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel + Ramucirumab DP | 9 | 46 | 15 |
| other | Neutropenia | Blood and lymphatic system disorders | Docetaxel + Icrucumab | 13 | 49 | 25 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Docetaxel | 4 | 45 | 8 |
1 to 10 of 555Source ClinicalTrials.gov
See all 555 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Docetaxel | ||
| Total, all-cause mortality | Docetaxel + Ramucirumab DP | ||
| Total, all-cause mortality | Docetaxel + Icrucumab | ||
| Total, other adverse events | Docetaxel | 45 | 45 |
| Total, other adverse events | Docetaxel + Ramucirumab DP | 46 | 46 |
| Total, other adverse events | Docetaxel + Icrucumab | 49 | 49 |
| Total, serious adverse events | Docetaxel | 19 | 45 |
| Total, serious adverse events | Docetaxel + Ramucirumab DP | 25 | 46 |
| Total, serious adverse events | Docetaxel + Icrucumab | 22 | 49 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26926681 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01282463
GET https://conductscience.org/api/trials/v1/NCT01282463/results?page=2