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

Primary Purpose

Urothelial Carcinoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ramucirumab

Docetaxel

Placebo

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Highlands Oncology Group
St. Jude Medical Center
UCLA Medical Center
USC Norris Cancer Hospital
SMO TRIO -Translational Research
Cancer Care Associates Medical Group
University of California, Davis - Health Systems
Central Coast Medical Oncology Corporation
University of Colorado
Pharmatech Oncology Inc
St Mary's Hospital Regional Cancer Center
Yale University School of Medicine
Southeast Florida Hematology/Oncology
Florida Cancer Specialists
Lakeland Regional Cancer Center
Sylvester Comprehensive Cancer Center
Florida Cancer Specialists
Southeastern Regional Medical Center
The Queen's Medical Center
Fort Wayne Oncology & Hematology
Alton Ochsner Medical Center
University of Maryland- Biological Sciences
Karmanos Cancer Institute
Mayo Clinic
University of Nebraska Medical Center
Cornell University Medical College
SUNY at Stony Brook
Oncology Hematology Care Inc.
University of Oklahoma Health Sciences Center
SMO Sarah Cannon Research Inst.
The Center for Cancer and Blood Disorders
Inova Comprehensive Cancer Care & Research Institute
University of Washington Medical Center
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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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ramucirumab + Docetaxel

Placebo + Docetaxel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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).

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 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.

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.

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).

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

Cmax of Ramucirumab at the end of ramucirumab infusion.

PK: Minimum Concentration (Cmin) of Ramucirumab

Cmin of Ramucirumab following administration every 3 weeks.

Number of Participants With Anti-Ramucirumab Antibodies

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

Full Information

NCT ID

NCT02426125

First Posted

April 21, 2015

Last Updated

August 17, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02426125

Brief Title

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

Acronym

RANGE

Official Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ramucirumab Plus Docetaxel Versus Placebo Plus Docetaxel in Patients With Locally Advanced or Unresectable or Metastatic Urothelial Carcinoma Who Progressed on or After Platinum-Based Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

July 13, 2015 (Actual)

Primary Completion Date

April 21, 2017 (Actual)

Study Completion Date

July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

530 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ramucirumab + Docetaxel

Arm Type

Experimental

Arm Description

Arm Title

Placebo + Docetaxel

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ramucirumab

Other Intervention Name(s)

LY3009806

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Intervention Description

Administered IV

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered IV

Primary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall Survival (OS)

Description

Time Frame

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

Title

Percentage of Participants With an Objective Response Rate (ORR)

Description

Time Frame

Randomization to Disease Progression (Up to 29.7 Months)

Title

Percentage of Participants With Disease Control Rate (DCR)

Description

Time Frame

Randomization to Disease Progression (Up to 29.7 Months)

Title

Duration of Response (DoR)

Description

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)

Title

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Cmax of Ramucirumab at the end of ramucirumab infusion.

Time Frame

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

Title

PK: Minimum Concentration (Cmin) of Ramucirumab

Description

Cmin of Ramucirumab following administration every 3 weeks.

Time Frame

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

Title

Number of Participants With Anti-Ramucirumab Antibodies

Description

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

Time Frame

29.7 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Highlands Oncology Group

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

St. Jude Medical Center

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

UCLA Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90024

Country

United States

Facility Name

USC Norris Cancer Hospital

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

SMO TRIO -Translational Research

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Cancer Care Associates Medical Group

City

Redondo Beach

State/Province

California

ZIP/Postal Code

90277

Country

United States

Facility Name

University of California, Davis - Health Systems

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

Central Coast Medical Oncology Corporation

City

Santa Monica

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

University of Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Pharmatech Oncology Inc

City

Denver

State/Province

Colorado

ZIP/Postal Code

80203

Country

United States

Facility Name

St Mary's Hospital Regional Cancer Center

City

Grand Junction

State/Province

Colorado

ZIP/Postal Code

81501

Country

United States

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

Facility Name

Southeast Florida Hematology/Oncology

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Lakeland Regional Cancer Center

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Sylvester Comprehensive Cancer Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Southeastern Regional Medical Center

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

The Queen's Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Fort Wayne Oncology & Hematology

City

Fort Wayne

State/Province

Indiana

ZIP/Postal Code

46845

Country

United States

Facility Name

Alton Ochsner Medical Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70121

Country

United States

Facility Name

University of Maryland- Biological Sciences

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Karmanos Cancer Institute

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55902

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198-7680

Country

United States

Facility Name

Cornell University Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

SUNY at Stony Brook

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

Oncology Hematology Care Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

SMO Sarah Cannon Research Inst.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

The Center for Cancer and Blood Disorders

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Inova Comprehensive Cancer Care & Research Institute

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22031

Country

United States

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

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.

City

Adelaide

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Footscray

ZIP/Postal Code

3011

Country

Australia

Facility Name

City

Randwick

ZIP/Postal Code

2031

Country

Australia

Facility Name

City

Subiaco

ZIP/Postal Code

6008

Country

Australia

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Toronto

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

City

Vancouver

ZIP/Postal Code

V5Z 4E6

Country

Canada

Facility Name

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

City

Caen

ZIP/Postal Code

14076

Country

France

Facility Name

City

Lille

ZIP/Postal Code

59020

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34070

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35062

Country

France

Facility Name

City

Dusseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

City

Homburg

ZIP/Postal Code

66421

Country

Germany

Facility Name

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

City

Marburg

ZIP/Postal Code

35043

Country

Germany

Facility Name

City

Tubingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

Patras

ZIP/Postal Code

26504

Country

Greece

Facility Name

City

Thessaloniki

ZIP/Postal Code

56403

Country

Greece

Facility Name

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

City

Miskolc

ZIP/Postal Code

3526

Country

Hungary

Facility Name

City

Haifa

ZIP/Postal Code

3525408

Country

Israel

Facility Name

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

City

Tel Hashomer

ZIP/Postal Code

5265601

Country

Israel

Facility Name

City

Tel-Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

City

Zerifin

ZIP/Postal Code

6093000

Country

Israel

Facility Name

City

Arezzo

ZIP/Postal Code

52100

Country

Italy

Facility Name

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20133

Country

Italy

Facility Name

City

Orbassano

ZIP/Postal Code

10043

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00152

Country

Italy

Facility Name

City

Verona

ZIP/Postal Code

37134

Country

Italy

Facility Name

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

City

Hidaka

ZIP/Postal Code

350-1298

Country

Japan

Facility Name

City

Hirosaki

ZIP/Postal Code

036-8563

Country

Japan

Facility Name

City

Kashiwa

ZIP/Postal Code

277-8577

Country

Japan

Facility Name

City

Kita-gun

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

City

Kobe

ZIP/Postal Code

650-0047

Country

Japan

Facility Name

City

Matsuyama

ZIP/Postal Code

791-0280

Country

Japan

Facility Name

City

Morioka

ZIP/Postal Code

020-8505

Country

Japan

Facility Name

City

Niigata

ZIP/Postal Code

951-8520

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

541-8567

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-8543

Country

Japan

Facility Name

City

Sendai

ZIP/Postal Code

980-8574

Country

Japan

Facility Name

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

City

Tsukuba

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

City

Seongnam

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03181

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06351

Country

Korea, Republic of

Facility Name

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

City

Culiacan

ZIP/Postal Code

80020

Country

Mexico

Facility Name

City

Mexico

ZIP/Postal Code

06760

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64570

Country

Mexico

Facility Name

City

Morelia

ZIP/Postal Code

58260

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

City

Sittard

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

City

Gdansk

ZIP/Postal Code

80-219

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

60-569

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

04-125

Country

Poland

Facility Name

City

Wieliszew

ZIP/Postal Code

05-135

Country

Poland

Facility Name

City

Baia Mare

ZIP/Postal Code

430110

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400058

Country

Romania

Facility Name

City

Craiova

ZIP/Postal Code

200347

Country

Romania

Facility Name

Ivanovo regional clinical oncology dispensary

City

Ivanovo

ZIP/Postal Code

153040

Country

Russian Federation

Facility Name

Republic Oncology Dispensary of MoH of Republic Tatarstan

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

Scientific research oncology institute n.a. P. A. Herzen

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Saint-Petersburg city clinical oncology dispensary

City

Saint Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

City

Saratov

ZIP/Postal Code

410054

Country

Russian Federation

Facility Name

City

Badajoz

ZIP/Postal Code

06080

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

City

Tainan

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

100

Country

Taiwan

Facility Name

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Facility Name

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

Facility Name

City

Malatya

ZIP/Postal Code

44280

Country

Turkey

Facility Name

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

City

Kyiv

ZIP/Postal Code

04107

Country

Ukraine

Facility Name

City

Lutsk

ZIP/Postal Code

63000

Country

Ukraine

Facility Name

City

Bebington

ZIP/Postal Code

CH63 4JY

Country

United Kingdom

Facility Name

City

Chelsea

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

EC1A 7BE

Country

United Kingdom

Facility Name

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

City

Sutton

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35388003

Citation

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.

Results Reference

derived

PubMed Identifier

34795131

Citation

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.

Results Reference

derived

PubMed Identifier

33160359

Citation

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.

Results Reference

derived

PubMed Identifier

31753727

Citation

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.

Results Reference

derived

PubMed Identifier

28916371

Citation

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.

Results Reference

derived

Links:

URL

https://trials.lilly.com/en-US/trial/97404

Description

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

Learn more about this trial

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

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