A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
NCT ID: NCT02426125
Last Updated: 2023-08-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
530 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-13
Study Completion Date
2022-07-26
Brief Summary
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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.
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Detailed Description
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Conditions
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Urothelial Carcinoma
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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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.
Group Type
EXPERIMENTAL
Ramucirumab
Intervention Type
DRUG
Administered IV
Docetaxel
Intervention Type
DRUG
Administered IV
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.
Group Type
PLACEBO_COMPARATOR
Docetaxel
Intervention Type
DRUG
Administered IV
Placebo
Intervention Type
DRUG
Administered IV
Interventions
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Ramucirumab
Administered IV
Intervention Type
DRUG
Docetaxel
Administered IV
Intervention Type
DRUG
Placebo
Administered IV
Intervention Type
DRUG
Other Intervention Names
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LY3009806
Eligibility Criteria
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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.
* 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.
* 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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Pharmatech Oncology Inc
Denver, Colorado, United States
Site Status
St Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States
Site Status
Yale University School of Medicine
New Haven, Connecticut, United States
Site Status
Southeast Florida Hematology/Oncology
Fort Lauderdale, Florida, United States
Site Status
Florida Cancer Specialists
Fort Myers, Florida, United States
Site Status
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Site Status
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Site Status
Florida Cancer Specialists
St. Petersburg, Florida, United States
Site Status
Highlands Oncology Group
Fayetteville, Arkansas, United States
Site Status
St. Jude Medical Center
Fullerton, California, United States
Site Status
UCLA Medical Center
Los Angeles, California, United States
Site Status
USC Norris Cancer Hospital
Los Angeles, California, United States
Site Status
SMO TRIO -Translational Research
Los Angeles, California, United States
Site Status
Cancer Care Associates Medical Group
Redondo Beach, California, United States
Site Status
University of California, Davis - Health Systems
Sacramento, California, United States
Site Status
Central Coast Medical Oncology Corporation
Santa Monica, California, United States
Site Status
University of Colorado
Aurora, Colorado, United States
Site Status
Southeastern Regional Medical Center
Newnan, Georgia, United States
Site Status
The Queen's Medical Center
Honolulu, Hawaii, United States
Site Status
Fort Wayne Oncology & Hematology
Fort Wayne, Indiana, United States
Site Status
Alton Ochsner Medical Center
New Orleans, Louisiana, United States
Site Status
University of Maryland- Biological Sciences
Baltimore, Maryland, United States
Site Status
Karmanos Cancer Institute
Detroit, Michigan, United States
Site Status
Mayo Clinic
Rochester, Minnesota, United States
Site Status
University of Nebraska Medical Center
Omaha, Nebraska, United States
Site Status
Cornell University Medical College
New York, New York, United States
Site Status
SUNY at Stony Brook
Stony Brook, New York, United States
Site Status
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States
Site Status
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Site Status
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, United States
Site Status
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Site Status
Inova Comprehensive Cancer Care & Research Institute
Fairfax, Virginia, United States
Site Status
University of Washington Medical Center
Seattle, Washington, United States
Site Status
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Adelaide, , Australia
Site Status
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Footscray, , Australia
Site Status
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Randwick, , Australia
Site Status
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Subiaco, , Australia
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Brussels, , Belgium
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Leuven, , Belgium
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Wilrijk, , Belgium
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Toronto, , Canada
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Vancouver, , Canada
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Herlev, , Denmark
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Odense, , Denmark
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Caen, , France
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Lille, , France
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Lyon, , France
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Montpellier, , France
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Paris, , France
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Rennes, , France
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Düsseldorf, , Germany
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Freiburg im Breisgau, , Germany
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Homburg, , Germany
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Jena, , Germany
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Marburg, , Germany
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Tübingen, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Pátrai, , Greece
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Thessaloniki, , Greece
Site Status
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Budapest, , Hungary
Site Status
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Miskolc, , Hungary
Site Status
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Haifa, , Israel
Site Status
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Kfar Saba, , Israel
Site Status
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Petah Tikva, , Israel
Site Status
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Tel Aviv, , Israel
Site Status
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Tel Litwinsky, , Israel
Site Status
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Ẕerifin, , Israel
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Arezzo, , Italy
Site Status
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Bologna, , Italy
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Milan, , Italy
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Orbassano, , Italy
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Rome, , Italy
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Verona, , Italy
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Bunkyō City, , Japan
Site Status
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Chiba, , Japan
Site Status
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Fukuoka, , Japan
Site Status
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Hidaka, , Japan
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Hirosaki, , Japan
Site Status
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Kashiwa, , Japan
Site Status
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Kita-gun, , Japan
Site Status
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Kobe, , Japan
Site Status
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Matsuyama, , Japan
Site Status
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Morioka, , Japan
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Niigata, , Japan
Site Status
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Osaka, , Japan
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Sapporo, , Japan
Site Status
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Sendai, , Japan
Site Status
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Suita-shi, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Tsukuba, , Japan
Site Status
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Aguascalientes, , Mexico
Site Status
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Culiacán, , Mexico
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México, , Mexico
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Monterrey, , Mexico
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Morelia, , Mexico
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Sittard, , Netherlands
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Gdansk, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Wieliszew, , Poland
Site Status
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Baia Mare, , Romania
Site Status
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Cluj-Napoca, , Romania
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Craiova, , Romania
Site Status
Ivanovo regional clinical oncology dispensary
Ivanovo, , Russia
Site Status
Republic Oncology Dispensary of MoH of Republic Tatarstan
Kazan', , Russia
Site Status
Scientific research oncology institute n.a. P. A. Herzen
Moscow, , Russia
Site Status
Saint-Petersburg city clinical oncology dispensary
Saint Petersburg, , Russia
Site Status
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Saratov, , Russia
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Daejeon, , South Korea
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Seongnam, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badajoz, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Ankara, , Turkey (Türkiye)
Site Status
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Antalya, , Turkey (Türkiye)
Site Status
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Edirne, , Turkey (Türkiye)
Site Status
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Istanbul, , Turkey (Türkiye)
Site Status
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Malatya, , Turkey (Türkiye)
Site Status
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Dnipropetrovsk, , Ukraine
Site Status
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Kyiv, , Ukraine
Site Status
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Lutsk, , Ukraine
Site Status
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Bebington, , United Kingdom
Site Status
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Chelsea, , United Kingdom
Site Status
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London, , United Kingdom
Site Status
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Nottingham, , United Kingdom
Site Status
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Southampton, , United Kingdom
Site Status
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Sutton, , United Kingdom
Site Status
Countries
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United States
Australia
Belgium
Canada
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Japan
Mexico
Netherlands
Poland
Romania
Russia
South Korea
Spain
Taiwan
Turkey (Türkiye)
Ukraine
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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https://trials.lilly.com/en-US/trial/97404
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer
Other Identifiers
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I4T-MC-JVDC
Identifier Type: OTHER
Identifier Source: secondary_id
2014-003655-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
15679
Identifier Type: -
Identifier Source: org_study_id
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