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



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:July 13, 2015
End Date:June 20, 2019

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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

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.


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.
We found this trial at
34
sites
3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Ivor Percent
Phone: 239-274-9930
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3525
Lakeland, Florida 33805
Principal Investigator: Madhavi Venigalla
Phone: 863-904-1900
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Lakeland, FL
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Adelaide,
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Aurora, Colorado 80045
Principal Investigator: Thomas Flaig
Phone: 303-724-3808
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2901 Liberty Heights Avenue
Baltimore, Maryland 21201
Principal Investigator: Heather Mannuel
Phone: 410-328-2567
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Principal Investigator: Benjamin Herms
Phone: 513-751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Denver, Colorado 80203
Principal Investigator: SMO Pharmatech Oncology Inc
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Detroit, Michigan 48201
Principal Investigator: Ulka Vaishampayan
Phone: 313-745-5111
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Fairfax, Virginia 22031
Principal Investigator: Jeanny Aragon-Ching
Phone: 703-970-6431
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Fayetteville, Arkansas 72703
Principal Investigator: Joseph Beck
Phone: 479-587-1700
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Fort Lauderdale, Florida 33308
Principal Investigator: David Lessen
Phone: 954-776-1800
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Fort Wayne, Indiana 46815
Principal Investigator: Sunil Babu
Phone: 317-436-0800
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Fort Worth, Texas 76104
Principal Investigator: Ray Page
Phone: 817-759-7000
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Fullerton, California 92835
Principal Investigator: William Lawler
Phone: 714-446-5804
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Fullerton, CA
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Grand Junction, Colorado 81501
Principal Investigator: Mark Hancock
Phone: 970-244-7164
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Principal Investigator: Charles Rosser
Phone: 808-546-3812
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Alexandra Drakaki
Phone: 310-206-5223
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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1441 Eastlake Avenue
Los Angeles, California 90033
Principal Investigator: David Quinn
Phone: 323-865-3956
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Los Angeles, California 90024
Principal Investigator: TRIO - Translational Research
Phone: 310-794-6500
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Miami, Florida 33136
Principal Investigator: Rakesh Singal
Phone: 305-243-9544
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Nashville, Tennessee 37203
Principal Investigator: John Hainsworth
Phone: 615-329-7615
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Principal Investigator: Daniel Petrylak
Phone: 203-200-4822
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Orleans, Louisiana 70121
Principal Investigator: Marc Matrana
Phone: 504-376-3863
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New York, New York
Principal Investigator: Scott Tagawa
Phone: 646-962-2072
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Newnan, Georgia 30265
Principal Investigator: Shahin Chowdhury
Phone: 770-400-6335
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Sofia Ghani
Phone: 405-271-4022
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: James Schwarz
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Redondo Beach, California 90277
Principal Investigator: Thomas Lowe
Phone: 310-750-3376
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Rochester, Minnesota 55905
Principal Investigator: Manish Kohli
Phone: 507-284-4080
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Sacramento, California 95817
Principal Investigator: Chong Xian Pan
Phone: 916-734-3771
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Saint Petersburg, Florida 33705
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Santa Monica, California 93454
Principal Investigator: Robert Dichmann
Phone: 805-349-1155
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Evan Yu
Phone: 206-288-1000
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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Stony Brook, New York 11794
Principal Investigator: Shenhong Wu
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