Bladder Cancer Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

530

Study ID:

NCT02426125

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 140 Locations for this study

See Locations Near You

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, 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 3, Canada
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Vancouver , V5Z 4, 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 , 35254, Israel
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Kfar Saba , 44281, Israel
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Petach Tikva , 49414, Israel
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Tel Hashomer , 52656, Israel
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Tel-Aviv , 64239, Israel
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Zerifin , 60930, 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 , 113-8, Japan
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Chiba , 260-8, Japan
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Fukuoka , 812-8, Japan
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Hidaka , 350-1, Japan
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Hirosaki , 036-8, Japan
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Kashiwa , 277-8, Japan
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Kita-gun , 761-0, Japan
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Kobe , 650-0, Japan
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Matsuyama , 791-0, Japan
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Morioka , 020-8, Japan
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Niigata , 951-8, Japan
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Osaka , 541-8, Japan
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Sapporo , 060-8, Japan
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Sendai , 980-8, Japan
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Suita-shi , 565-0, Japan
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Tokyo , 135-8, Japan
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Tsukuba , 305-8, 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 , 463-7, 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
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Mexico , 06760, Mexico
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Monterrey , 64570, Mexico
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Morelia , 58260, Mexico
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Amsterdam , 1066 , Netherlands
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Arnhem , 6815 , Netherlands
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Maastricht , 6229 , Netherlands
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Rotterdam , 3075 , Netherlands
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Sittard , 6162 , Netherlands
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Gdansk , 80-21, Poland
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Poznan , 60-56, Poland
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Warszawa , 04-12, Poland
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Wieliszew , 05-13, Poland
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Baia Mare , 43011, Romania
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Cluj-Napoca , 40005, Romania
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Craiova , 20034, Romania
Ivanovo regional clinical oncology dispensary
Ivanovo , 15304, Russian Federation
Republic Oncology Dispensary of MoH of Republic Tatarstan
Kazan , 42002, Russian Federation
Scientific research oncology institute n.a. P. A. Herzen
Moscow , 12528, Russian Federation
Saint-Petersburg city clinical oncology dispensary
Saint Petersburg , 19825, Russian Federation
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.
Saratov , 41005, Russian Federation
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.
Badajoz , 06080, Spain
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.
Barcelona , 08907, Spain
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.
Madrid , 28034, Spain
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.
Kaohsiung , 83301, Taiwan
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.
Taichung , 40705, Taiwan
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.
Tainan , 71004, Taiwan
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.
Taipei , 100, Taiwan
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.
Ankara , 06100, Turkey
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.
Antalya , 07059, Turkey
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.
Edirne , 22030, Turkey
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
Istanbul , 34098, Turkey
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.
Malatya , 44280, Turkey
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.
Dnipropetrovsk , 49102, Ukraine
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.
Kyiv , 04107, Ukraine
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.
Lutsk , 63000, Ukraine
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.
Bebington , CH63 , United Kingdom
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
Chelsea , W6 8R, United Kingdom
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.
London , EC1A , United Kingdom
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.
Nottingham , NG5 1, United Kingdom
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.
Southampton , SO16 , United Kingdom
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.
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 3

Estimated Enrollment:

530

Study ID:

NCT02426125

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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