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CompletedNCT02426125RANGEUpdated Aug 21, 2023Results posted

A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer

A Phase 3 interventional study of Ramucirumab and Docetaxel in Urothelial Carcinoma, sponsored by Eli Lilly and Company. Completed at 141 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
530
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug ramucirumab in combination with docetaxel in participants with urothelial cancer who failed prior platinum-based therapy.

02

Conditions studied

  • Urothelial Carcinoma

Keywords

  • carcinoma of the bladder
  • carcinoma of the urethra
  • carcinoma the of ureter
  • carcinoma of the renal pelvis
  • transitional cell carcinoma
  • transitional cell tumor
  • RANGE
  • bladder cancer
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 530 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have histologically or cytologically confirmed, locally advanced or unresectable or metastatic urothelial (transitional cell) carcinoma of the bladder, urethra, ureter, or renal pelvis.
  • Had disease progression while on a platinum containing regimen in the first-line setting or within 14 months after completing the first-line platinum regimen. Participants who received treatment with one immune checkpoint inhibitor regimen are eligible (for example Programmed death 1 (PD-1), Programmed death-ligand 1 (PDL1), or CTLA4) and may have a longer interval since prior platinum-containing therapy (≤24 months).
  • Have a life expectancy of ≥3 months.
  • Have received no more than one prior systemic chemotherapy regimen in the relapsed or metastatic setting. Prior treatment with no more than one prior immune checkpoint inhibitor is permitted and will not be considered as a line of systemic chemotherapy.
  • Have measurable disease or nonmeasurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
  • Have an Eastern Cooperative Oncology Group (ECOG) of 0 or 1.
  • Have adequate hematologic function.
  • Have adequate coagulation function.
  • Have adequate hepatic function.

  • The participant does not have:

    • cirrhosis at a level of Child-Pugh B (or worse)
    • cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
  • Have adequate renal function as defined by creatinine clearance >30 milliliters/minute.
  • Have urinary protein ≤1+ on dipstick or routine urinalysis.
  • The participant is willing to provide blood, urine, and tissue samples for research purposes.

Exclusion criteria

Exclusion Criteria:

  • Have received more than one prior systemic chemotherapy regimen for metastatic disease.
  • Have received prior systemic taxane therapy for transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis in any setting (neoadjuvant, adjuvant, metastatic).
  • Have received more than one prior antiangiogenic agent (that is, bevacizumab, sorafenib, sunitinib) for TCC of the urothelium.
  • Have received radiation therapy within 4 weeks (≤4 weeks) prior to randomization or has not recovered from toxic effects of the treatment that was given >4 weeks prior to randomization.
  • Have a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
  • Have experienced a Grade ≥3 bleeding event within 3 months (≤3 months) prior to randomization.
  • Have uncontrolled intercurrent illness, including, but not limited to symptomatic anemia, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness, or any other serious uncontrolled medical disorders.
  • Have experienced any arterial or venothrombotic or thromboembolic events, including, but not limited to myocardial infarction, transient ischemic attack, or cerebrovascular accident, within 6 months (≤6 months) prior to randomization.
  • Have known untreated brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease.
  • Have human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome-related illness.
  • Have undergone major surgery within 28 days (≤28 days) prior to randomization or subcutaneous venous access device placement within 7 days (≤7 days) prior to randomization.
  • The participant is pregnant prior to randomization or lactating.
  • Have a concurrent malignancy or had another malignancy within 5 years (≤5 years) of study enrollment.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
530 participants (actual)

Study arms

  • Experimental
    Ramucirumab + Docetaxel

    Ramucirumab (10 milligram/kilogram \[mg/kg\]) intravenously (IV) plus docetaxel (75 milligram/square meter \[mg/m²\]) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Drug: Ramucirumab · Drug: Docetaxel

  • Placebo comparator
    Placebo + Docetaxel

    Placebo IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.

    Drug: Docetaxel · Drug: Placebo

Interventions

  • DrugRamucirumab

    Administered IV

    Also known as: LY3009806

  • DrugDocetaxel

    Administered IV

  • DrugPlacebo

    Administered IV

06

What researchers measure

Primary outcomes

  1. Progression Free Survival (PFS)

    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.

    Time frame: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)

Secondary outcomes

  1. Overall Survival (OS)

    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.

    Time frame: Randomization to Date of Death from Any Cause (Up to 31.1 Months)

  2. Percentage of Participants With an Objective Response Rate (ORR)

    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.

    Time frame: Randomization to Disease Progression (Up to 29.7 Months)

  3. Percentage of Participants With Disease Control Rate (DCR)

    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).

    Time frame: Randomization to Disease Progression (Up to 29.7 Months)

  4. Duration of Response (DoR)

    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.

    Time frame: 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)

  5. 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

    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.

    Time frame: Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)

  6. Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

    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.

    Time frame: Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)

  7. Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

    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).

    Time frame: Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)

  8. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

    Cmax of Ramucirumab at the end of ramucirumab infusion.

    Time frame: Cycle 1 and Cycle 9, Day 1: Predose, Postdose

  9. PK: Minimum Concentration (Cmin) of Ramucirumab

    Cmin of Ramucirumab following administration every 3 weeks.

    Time frame: Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)

  10. Number of Participants With Anti-Ramucirumab Antibodies

    Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.

    Time frame: 29.7 Months

07

Results

Posted Mar 8, 2019

Participant flow

Participant flow — Overall Study
MilestoneRamucirumab + DocetaxelPlacebo + Docetaxel
Started263267
Received at least one dose of study drug258265
Completed4639
Not completed217228
Withdrew: Lost to follow-up1412
Withdrew: Withdrawal by subject1314
Withdrew: Death185200
Withdrew: Randomized, but never treated52

Outcome measures

PrimaryProgression Free Survival (PFS)

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.

Time frame:
Randomization to Radiological Disease Progression or Death from Any Cause (Up to 18 Months)
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsRamucirumab + DocetaxelPlacebo + Docetaxel
Progression Free Survival (PFS)4.07 (2.96 to 4.47)2.76 (2.60 to 2.96)
Statistical analysis
  • Ramucirumab + Docetaxel vs Placebo + Docetaxel · Log Rank · p = 0.0118 (Stratified) · Hazard ratio (hr): 0.757 · 95% CI 0.607 to 0.943Stratified
SecondaryOverall Survival (OS)

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.

Time frame:
Randomization to Date of Death from Any Cause (Up to 31.1 Months)
Reported as:
Median · Months
Overall Survival (OS)
MonthsRamucirumab + DocetaxelPlacebo + Docetaxel
Overall Survival (OS)9.40 (7.89 to 11.43)7.85 (7.00 to 9.30)
Statistical analysis
  • Ramucirumab + Docetaxel vs Placebo + Docetaxel · Log Rank · p = 0.2461 (Stratified) · Hazard ratio (hr): 0.887 · 95% CI 0.724 to 1.086Stratified
SecondaryPercentage of Participants With an Objective Response Rate (ORR)

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.

Time frame:
Randomization to Disease Progression (Up to 29.7 Months)
Reported as:
Number · percentage of participants
Percentage of Participants With an Objective Response Rate (ORR)
percentage of participantsRamucirumab + DocetaxelPlacebo + Docetaxel
Percentage of Participants With an Objective Response Rate (ORR)25.9 (20.6 to 31.1)13.9 (9.7 to 18.0)
SecondaryPercentage of Participants With Disease Control Rate (DCR)

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).

Time frame:
Randomization to Disease Progression (Up to 29.7 Months)
Reported as:
Number · percentage of participants
Percentage of Participants With Disease Control Rate (DCR)
percentage of participantsRamucirumab + DocetaxelPlacebo + Docetaxel
Percentage of Participants With Disease Control Rate (DCR)65.4 (59.7 to 71.1)55.1 (49.1 to 61.0)
SecondaryDuration of Response (DoR)

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.

Time frame:
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)
Reported as:
Median · Months
Duration of Response (DoR)
MonthsRamucirumab + DocetaxelPlacebo + Docetaxel
Duration of Response (DoR)5.32 (3.94 to 6.87)4.17 (3.29 to 5.55)
Statistical analysis
  • Ramucirumab + Docetaxel vs Placebo + Docetaxel · Log Rank · p = 0.189 · Hazard ratio (hr): 0.740 · 95% CI 0.473 to 1.158
SecondaryTime 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

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.

Time frame:
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
Reported as:
Median · Months
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
MonthsRamucirumab + DocetaxelPlacebo + Docetaxel
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 Scale6.87 (4.24 to 8.90)4.60 (3.52 to 5.55)
Statistical analysis
  • Ramucirumab + Docetaxel vs Placebo + Docetaxel · Log Rank · p = 0.357 (Stratified) · Hazard ratio (hr): 0.879 · 95% CI 0.663 to 1.167Stratified
SecondaryChange From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score

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.

Time frame:
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
Reported as:
Mean · units on a scale
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score
units on a scaleRamucirumab + DocetaxelPlacebo + Docetaxel
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Index Score-0.10 ± 0.26-0.19 ± 0.26
SecondaryChange From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)

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).

Time frame:
Randomization, 30 Days After Treatment Discontinuation (Up to 18 Months)
Reported as:
Mean · millimeter (mm)
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)
millimeter (mm)Ramucirumab + DocetaxelPlacebo + Docetaxel
Change From Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS)-7.87 ± 17.95-10.91 ± 16.77
SecondaryPharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

Cmax of Ramucirumab at the end of ramucirumab infusion.

Time frame:
Cycle 1 and Cycle 9, Day 1: Predose, Postdose
Reported as:
Geometric mean · microgram/milliliter (μg/mL)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
microgram/milliliter (μg/mL)Ramucirumab + Docetaxel
Cycle 1199 ± 28
Cycle 9265 ± 29
SecondaryPK: Minimum Concentration (Cmin) of Ramucirumab

Cmin of Ramucirumab following administration every 3 weeks.

Time frame:
Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)
Reported as:
Geometric mean · μg/mL
PK: Minimum Concentration (Cmin) of Ramucirumab
μg/mLRamucirumab + Docetaxel
Cycle 214.9 ± 64
Cycle 323.5 ± 63
Cycle 532.5 ± 70
Cycle 948.9 ± 56
SecondaryNumber of Participants With Anti-Ramucirumab Antibodies

Number of participants with positive treatment emergent anti-ramucirumab antibodies was summarized by treatment group.

Time frame:
29.7 Months
Reported as:
Count of participants · Participants
Number of Participants With Anti-Ramucirumab Antibodies
ParticipantsRamucirumab + DocetaxelPlacebo + Docetaxel
Number of Participants With Anti-Ramucirumab Antibodies38

Adverse events

Collected over Up to 64.7 Months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ramucirumab + Docetaxel193/258 (74.8%)111/258 (43%)241/258 (93.4%)
Placebo+Docetaxel209/265 (78.9%)107/265 (40.4%)251/265 (94.7%)
Most frequent serious events
Showing 10 of 139
Most frequent serious events
EventRamucirumab + DocetaxelPlacebo+Docetaxel
Febrile neutropeniaBlood and lymphatic system disorders17/25813/265
Urinary tract infectionInfections and infestations10/25811/265
PyrexiaGeneral disorders3/2589/265
PneumoniaInfections and infestations5/2588/265
SepsisInfections and infestations7/2585/265
Pleural effusionRespiratory, thoracic and mediastinal disorders0/2587/265
DiarrhoeaGastrointestinal disorders6/2584/265
HaematuriaRenal and urinary disorders4/2586/265
Female genital tract fistulaReproductive system and breast disorders1/490/51
FatigueGeneral disorders5/2582/265
Most frequent other events
Showing 10 of 544
Most frequent other events
EventRamucirumab + DocetaxelPlacebo+Docetaxel
FatigueGeneral disorders98/258106/265
AlopeciaSkin and subcutaneous tissue disorders66/25894/265
Decreased appetiteMetabolism and nutrition disorders82/25864/265
DiarrhoeaGastrointestinal disorders81/25856/265
AnaemiaBlood and lymphatic system disorders50/25876/265
NauseaGastrointestinal disorders71/25855/265
StomatitisGastrointestinal disorders66/25830/265
PyrexiaGeneral disorders44/25842/265
ConstipationGastrointestinal disorders35/25845/265
VomitingGastrointestinal disorders41/25840/265

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)Ramucirumab + DocetaxelPlacebo + DocetaxelTotal
Mean64.6 ± 9.964.8 ± 9.264.7 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Ramucirumab + DocetaxelPlacebo + DocetaxelTotal
Female5052102
Male213215428
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ramucirumab + DocetaxelPlacebo + DocetaxelTotal
Hispanic or Latino131023
Not Hispanic or Latino208219427
Unknown or Not Reported423880
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Ramucirumab + DocetaxelPlacebo + DocetaxelTotal
American Indian or Alaska Native101
Asian5461115
Native Hawaiian or Other Pacific Islander000
Black or African American325
White203204407
More than one race000
Unknown or Not Reported202
Region of Enrollment
Region of Enrollment(Participants)Ramucirumab + DocetaxelPlacebo + DocetaxelTotal
Romania5510
Hungary5813
United States171835
Japan243054
Ukraine538
United Kingdom182442
Russia181230
Spain221537
Greece131326
Canada459
South Korea16925
Netherlands171835
Turkey111728
Belgium617
Taiwan131831
Denmark5611
Poland448
Italy231437
Mexico314
Israel71118
Australia6612
France161834
Germany51116
08

Study locations

141 sites
  • Highlands Oncology Group
    Fayetteville, Arkansas 72703, United States
  • St. Jude Medical Center
    Fullerton, California 92835, United States
  • UCLA Medical Center
    Los Angeles, California 90024, United States
  • USC Norris Cancer Hospital
    Los Angeles, California 90033, United States
  • SMO TRIO -Translational Research
    Los Angeles, California 90095, United States
  • Cancer Care Associates Medical Group
    Redondo Beach, California 90277, United States
  • University of California, Davis - Health Systems
    Sacramento, California 95817, United States
  • Central Coast Medical Oncology Corporation
    Santa Monica, California 93454, United States
  • University of Colorado
    Aurora, Colorado 80045, United States
  • Pharmatech Oncology Inc
    Denver, Colorado 80203, United States
  • St Mary's Hospital Regional Cancer Center
    Grand Junction, Colorado 81501, United States
  • Yale University School of Medicine
    New Haven, Connecticut 06520, United States
  • Southeast Florida Hematology/Oncology
    Fort Lauderdale, Florida 33308, United States
  • Florida Cancer Specialists
    Fort Myers, Florida 33916, United States
  • Lakeland Regional Cancer Center
    Lakeland, Florida 33805, United States
  • Sylvester Comprehensive Cancer Center
    Miami, Florida 33136, United States
  • Florida Cancer Specialists
    Saint Petersburg, Florida 33705, United States
  • Southeastern Regional Medical Center
    Newnan, Georgia 30265, United States
  • The Queen's Medical Center
    Honolulu, Hawaii 96813, United States
  • Fort Wayne Oncology & Hematology
    Fort Wayne, Indiana 46845, United States
  • Alton Ochsner Medical Center
    New Orleans, Louisiana 70121, United States
  • University of Maryland- Biological Sciences
    Baltimore, Maryland 21201, United States
  • Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Mayo Clinic
    Rochester, Minnesota 55902, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-7680, United States
  • Cornell University Medical College
    New York, New York 10021, United States
  • SUNY at Stony Brook
    Stony Brook, New York 11794, United States
  • Oncology Hematology Care Inc.
    Cincinnati, Ohio 45242, United States
  • University of Oklahoma Health Sciences Center
    Oklahoma City, Oklahoma 73104, United States
  • SMO Sarah Cannon Research Inst.
    Nashville, Tennessee 37203, United States
  • The Center for Cancer and Blood Disorders
    Fort Worth, Texas 76104, United States
  • Inova Comprehensive Cancer Care & Research Institute
    Fairfax, Virginia 22031, United States
  • University of Washington Medical Center
    Seattle, Washington 98109, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Adelaide, 5000, Australia
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    Footscray, 3011, Australia
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    Randwick, 2031, Australia
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    Subiaco, 6008, Australia
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    Brussels, 1200, Belgium
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    Leuven, 3000, Belgium
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    Wilrijk, 2610, Belgium
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    Toronto, M4N 3M5, Canada
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    Vancouver, V5Z 4E6, Canada
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    Herlev, 2730, Denmark
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    Odense, 5000, Denmark
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    Caen, 14076, France
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    Lille, 59020, France
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    Lyon, 69373, France
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    Montpellier, 34070, France
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    Paris, 75015, France
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    Rennes, 35062, France
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    Dusseldorf, 40225, Germany
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    Freiburg, 79106, Germany
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    Homburg, 66421, Germany
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    Jena, 07740, Germany
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    Marburg, 35043, Germany
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    Tubingen, 72076, Germany
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    Athens, 11528, Greece
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    Heraklion, 71110, Greece
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    Patras, 26504, Greece
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    Thessaloniki, 56403, Greece
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    Budapest, 1122, Hungary
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    Miskolc, 3526, Hungary
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    Haifa, 3525408, Israel
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    Kfar Saba, 4428164, Israel
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    Petach Tikva, 4941492, Israel
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    Tel Hashomer, 5265601, Israel
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    Tel-Aviv, 6423906, Israel
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    Zerifin, 6093000, Israel
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    Arezzo, 52100, Italy
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    Bologna, 40138, Italy
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    Milano, 20133, Italy
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    Orbassano, 10043, Italy
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    Rome, 00152, Italy
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    Verona, 37134, Italy
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    Bunkyo-ku, 113-8431, Japan
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    Chiba, 260-8717, Japan
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    Fukuoka, 812-8582, Japan
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    Hidaka, 350-1298, Japan
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    Hirosaki, 036-8563, Japan
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    Kashiwa, 277-8577, Japan
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    Kita-gun, 761-0793, Japan
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    Kobe, 650-0047, Japan
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    Matsuyama, 791-0280, Japan
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    Morioka, 020-8505, Japan
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    Niigata, 951-8520, Japan
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    Osaka, 541-8567, Japan
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    Sapporo, 060-8543, Japan
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    Sendai, 980-8574, Japan
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    Suita-shi, 565-0871, Japan
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    Tokyo, 135-8550, Japan
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    Tsukuba, 305-8576, Japan
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    Daejeon, 35015, Korea, Republic of
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    Seongnam-si, 13620, Korea, Republic of
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    Seongnam, 463-707, Korea, Republic of
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    Seoul, 03181, Korea, Republic of
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    Seoul, 03722, Korea, Republic of
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    Seoul, 05505, Korea, Republic of
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    Seoul, 06351, Korea, Republic of
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    Aguascalientes, 20230, Mexico
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    Culiacan, 80020, Mexico

Showing the first 100 of 141 sites across 23 countries.

09

References and documents

Publications

  • van der Heijden MS, Powles T, Petrylak D, de Wit R, Necchi A, Sternberg CN, Matsubara N, Nishiyama H, Castellano D, Hussain SA, Bamias A, Gakis G, Lee JL, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Eigl BJ, Hozak RR, Rasmussen ER, Xia MS, Rhodes R, Wijayawardana S, Bell-McGuinn KM, Aggarwal A, Drakaki A. Predictive biomarkers for survival benefit with ramucirumab in urothelial cancer in the RANGE trial. Nat Commun. 2022 Apr 6;13(1):1878. doi: 10.1038/s41467-022-29441-y. PubMed 35388003 ↗
  • Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387. PubMed 34795131 ↗
  • Necchi A, Nishiyama H, Matsubara N, Lee JL, Petrylak DP, de Wit R, Drakaki A, Liepa AM, Mao H, Bell-McGuinn K, Powles T. Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum-refractory advanced urothelial carcinoma (RANGE). BMC Urol. 2020 Nov 7;20(1):181. doi: 10.1186/s12894-020-00752-w. PubMed 33160359 ↗
  • Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain SA, Flechon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Geczi L, Ou YC, Coskun HS, Su WP, Bedke J, Gakis G, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Garcia Del Muro X, Rodriguez-Vida A, Cicin I, Harputluoglu H, Tagawa ST, Vaishampayan U, Aragon-Ching JB, Hamid O, Liepa AM, Wijayawardana S, Russo F, Walgren RA, Zimmermann AH, Hozak RR, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): overall survival and updated results of a randomised, double-blind, phase 3 trial. Lancet Oncol. 2020 Jan;21(1):105-120. doi: 10.1016/S1470-2045(19)30668-0. Epub 2019 Nov 18. PubMed 31753727 ↗
  • Petrylak DP, de Wit R, Chi KN, Drakaki A, Sternberg CN, Nishiyama H, Castellano D, Hussain S, Flechon A, Bamias A, Yu EY, van der Heijden MS, Matsubara N, Alekseev B, Necchi A, Geczi L, Ou YC, Coskun HS, Su WP, Hegemann M, Percent IJ, Lee JL, Tucci M, Semenov A, Laestadius F, Peer A, Tortora G, Safina S, Del Muro XG, Rodriguez-Vida A, Cicin I, Harputluoglu H, Widau RC, Liepa AM, Walgren RA, Hamid O, Zimmermann AH, Bell-McGuinn KM, Powles T; RANGE study investigators. Ramucirumab plus docetaxel versus placebo plus docetaxel in patients with locally advanced or metastatic urothelial carcinoma after platinum-based therapy (RANGE): a randomised, double-blind, phase 3 trial. Lancet. 2017 Nov 18;390(10109):2266-2277. doi: 10.1016/S0140-6736(17)32365-6. Epub 2017 Sep 12. PubMed 28916371 ↗

Study documents

  • Study protocol · Jan 14, 2015
  • Statistical analysis plan · Feb 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02426125
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 24, 2015
Start date
Jul 13, 2015
Primary completion
Apr 21, 2017
Completion
Jul 26, 2022
Results posted
Mar 8, 2019
Last update
Aug 21, 2023

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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