NCT02426125

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
530

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_3

Geographic Reach
23 countries

141 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

July 13, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 8, 2019

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2022

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

April 21, 2015

Results QC Date

January 25, 2019

Last Update Submit

August 17, 2023

Conditions

Urothelial Carcinoma

Keywords

carcinoma of the bladdercarcinoma of the urethracarcinoma the of uretercarcinoma of the renal pelvistransitional cell carcinomatransitional cell tumorRANGEbladder cancer

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS)

    PFS defined as time from first day of therapy to first evidence of disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or death from any cause. Progressive Disease (PD) is at least 20% increase in sum of diameters of target lesions, with reference being the smallest sum on study and plus absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If participant does not have complete baseline disease assessment, then PFS time was censored at date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for participant. If participant is not known to have died or have objective progression as of data inclusion cutoff date for analysis, PFS time was censored at last adequate tumor assessment date.

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

Secondary Outcomes (10)

  • Overall Survival (OS)

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

  • Percentage of Participants With an Objective Response Rate (ORR)

    Randomization to Disease Progression (Up to 29.7 Months)

  • Percentage of Participants With Disease Control Rate (DCR)

    Randomization to Disease Progression (Up to 29.7 Months)

  • Duration of Response (DoR)

    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)

  • 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

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

  • +5 more secondary outcomes

Study Arms (2)

Ramucirumab + Docetaxel

EXPERIMENTAL

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

Drug: RamucirumabDrug: Docetaxel

Placebo + Docetaxel

PLACEBO COMPARATOR

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

Drug: DocetaxelDrug: Placebo

Interventions

RamucirumabDRUG

Administered IV

Also known as: LY3009806
Ramucirumab + Docetaxel
DocetaxelDRUG

Administered IV

Placebo + DocetaxelRamucirumab + Docetaxel
PlaceboDRUG

Administered IV

Placebo + Docetaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (141)

Highlands Oncology Group

Fayetteville, Arkansas, 72703, United States

Location

St. Jude Medical Center

Fullerton, California, 92835, United States

Location

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

USC Norris Cancer Hospital

Los Angeles, California, 90033, United States

Location

SMO TRIO -Translational Research

Los Angeles, California, 90095, United States

Location

Cancer Care Associates Medical Group

Redondo Beach, California, 90277, United States

Location

University of California, Davis - Health Systems

Sacramento, California, 95817, United States

Location

Central Coast Medical Oncology Corporation

Santa Monica, California, 93454, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Pharmatech Oncology Inc

Denver, Colorado, 80203, United States

Location

St Mary's Hospital Regional Cancer Center

Grand Junction, Colorado, 81501, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Southeast Florida Hematology/Oncology

Fort Lauderdale, Florida, 33308, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33916, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Florida Cancer Specialists

St. Petersburg, Florida, 33705, United States

Location

Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

Location

The Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Fort Wayne Oncology & Hematology

Fort Wayne, Indiana, 46845, United States

Location

Alton Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

University of Maryland- Biological Sciences

Baltimore, Maryland, 21201, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-7680, United States

Location

Cornell University Medical College

New York, New York, 10021, United States

Location

SUNY at Stony Brook

Stony Brook, New York, 11794, United States

Location

Oncology Hematology Care Inc.

Cincinnati, Ohio, 45242, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

SMO Sarah Cannon Research Inst.

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Inova Comprehensive Cancer Care & Research Institute

Fairfax, Virginia, 22031, United States

Location

University of Washington Medical Center

Seattle, Washington, 98109, United States

Location

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

Location

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Footscray, 3011, Australia

Location

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Randwick, 2031, Australia

Location

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Subiaco, 6008, Australia

Location

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Brussels, 1200, Belgium

Location

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Leuven, 3000, Belgium

Location

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Wilrijk, 2610, Belgium

Location

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Toronto, M4N 3M5, Canada

Location

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Vancouver, V5Z 4E6, Canada

Location

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Herlev, 2730, Denmark

Location

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Odense, 5000, Denmark

Location

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Caen, 14076, France

Location

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Lille, 59020, France

Location

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Lyon, 69373, France

Location

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Montpellier, 34070, France

Location

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Paris, 75015, France

Location

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Rennes, 35062, France

Location

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Düsseldorf, 40225, Germany

Location

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Freiburg im Breisgau, 79106, Germany

Location

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Homburg, 66421, Germany

Location

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Jena, 07740, Germany

Location

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Marburg, 35043, Germany

Location

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Tübingen, 72076, Germany

Location

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Athens, 11528, Greece

Location

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Heraklion, 71110, Greece

Location

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Pátrai, 26504, Greece

Location

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Thessaloniki, 56403, Greece

Location

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Budapest, 1122, Hungary

Location

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Miskolc, 3526, Hungary

Location

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Haifa, 3525408, Israel

Location

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Kfar Saba, 4428164, Israel

Location

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Petah Tikva, 4941492, Israel

Location

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Tel Aviv, 6423906, Israel

Location

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Tel Litwinsky, 5265601, Israel

Location

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Ẕerifin, 6093000, Israel

Location

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Arezzo, 52100, Italy

Location

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Bologna, 40138, Italy

Location

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Milan, 20133, Italy

Location

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Orbassano, 10043, Italy

Location

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Rome, 00152, Italy

Location

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Verona, 37134, Italy

Location

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Bunkyō City, 113-8431, Japan

Location

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Chiba, 260-8717, Japan

Location

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Fukuoka, 812-8582, Japan

Location

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Hidaka, 350-1298, Japan

Location

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Hirosaki, 036-8563, Japan

Location

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Kashiwa, 277-8577, Japan

Location

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Kita-gun, 761-0793, Japan

Location

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Kobe, 650-0047, Japan

Location

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Matsuyama, 791-0280, Japan

Location

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Morioka, 020-8505, Japan

Location

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Niigata, 951-8520, Japan

Location

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Osaka, 541-8567, Japan

Location

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Sapporo, 060-8543, Japan

Location

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Sendai, 980-8574, Japan

Location

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Suita-shi, 565-0871, Japan

Location

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Tokyo, 135-8550, Japan

Location

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Tsukuba, 305-8576, Japan

Location

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Aguascalientes, 20230, Mexico

Location

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Culiacán, 80020, Mexico

Location

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México, 06760, Mexico

Location

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Monterrey, 64570, Mexico

Location

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Morelia, 58260, Mexico

Location

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Amsterdam, 1066 CX, Netherlands

Location

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Arnhem, 6815 AD, Netherlands

Location

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Maastricht, 6229 HX, Netherlands

Location

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Rotterdam, 3075 EA, Netherlands

Location

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Sittard, 6162 BG, Netherlands

Location

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Gdansk, 80-219, Poland

Location

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Poznan, 60-569, Poland

Location

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Warsaw, 04-125, Poland

Location

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Wieliszew, 05-135, Poland

Location

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Baia Mare, 430110, Romania

Location

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Cluj-Napoca, 400058, Romania

Location

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Craiova, 200347, Romania

Location

Ivanovo regional clinical oncology dispensary

Ivanovo, 153040, Russia

Location

Republic Oncology Dispensary of MoH of Republic Tatarstan

Kazan', 420029, Russia

Location

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

Moscow, 125284, Russia

Location

Saint-Petersburg city clinical oncology dispensary

Saint Petersburg, 198255, Russia

Location

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Saratov, 410054, Russia

Location

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Daejeon, 35015, South Korea

Location

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Seongnam, 463-707, South Korea

Location

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Seongnam-si, 13620, South Korea

Location

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Seoul, 03181, South Korea

Location

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Seoul, 03722, South Korea

Location

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Seoul, 05505, South Korea

Location

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Seoul, 06351, South Korea

Location

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Badajoz, 06080, Spain

Location

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Barcelona, 08907, Spain

Location

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Madrid, 28034, Spain

Location

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Kaohsiung City, 83301, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Tainan, 71004, Taiwan

Location

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Taipei, 100, Taiwan

Location

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Ankara, 06100, Turkey (Türkiye)

Location

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Antalya, 07059, Turkey (Türkiye)

Location

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Edirne, 22030, Turkey (Türkiye)

Location

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Istanbul, 34098, Turkey (Türkiye)

Location

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Malatya, 44280, Turkey (Türkiye)

Location

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Dnipropetrovsk, 49102, Ukraine

Location

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Kyiv, 04107, Ukraine

Location

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Lutsk, 63000, Ukraine

Location

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Bebington, CH63 4JY, United Kingdom

Location

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Chelsea, W6 8RF, United Kingdom

Location

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London, EC1A 7BE, United Kingdom

Location

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Nottingham, NG5 1PB, United Kingdom

Location

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Southampton, SO16 6YD, United Kingdom

Location

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Sutton, SM2 5PT, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 35388003DERIVED

  • 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.

    PMID: 34795131DERIVED

  • 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.

    PMID: 33160359DERIVED

  • 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.

    PMID: 31753727DERIVED

  • 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.

    PMID: 28916371DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Transitional CellUrinary Bladder NeoplasmsUrethral Neoplasms

Interventions

RamucirumabDocetaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUrethral Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 24, 2015

Study Start

July 13, 2015

Primary Completion

April 21, 2017

Study Completion

July 26, 2022

Last Updated

August 21, 2023

Results First Posted

March 8, 2019

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
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.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

ME(5)TU(5)UA(3)KR(7)DE(6)BE(3)DK(2)ES(3)TW(4)FR(6)IL(6)PL(4)JP(17)GR(4)HU(2)US(33)RO(3)GB(6)NL(5)CA(2)RU(5)AU(4)IT(6)