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ACTIVE NOT RECRUITING
NCT02711553
PHASE2

A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

Official title: Randomized, Double-Blind, Phase 2 Study of Ramucirumab or Merestinib or Placebo Plus Cisplatin and Gemcitabine as First-Line Treatment in Patients With Advanced or Metastatic Biliary Tract Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

309

Start Date

2016-05-19

Completion Date

2026-12

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

Ramucirumab

Administered IV

DRUG

Merestinib

Administered orally

DRUG

Cisplatin

Administered IV

DRUG

Gemcitabine

Administered IV

DRUG

Placebo Oral

Administered orally

DRUG

Placebo IV

Administered IV

Locations (82)

The University of Arizona Cancer Center

Tucson, Arizona, United States

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

University of Florida School of Medicine

Gainesville, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University Medical School

City of Saint Peters, Missouri, United States

Washington University Medical School

Creve Coeur, Missouri, United States

Washington University Medical School

St Louis, Missouri, United States

Washington University Medical School

St Louis, Missouri, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Florida Cancer Specialists

Nashville, Tennessee, United States

Tennessee Oncology PLLC

Nashville, Tennessee, United States

Alexander Fleming

CABA, BS, Argentina

Hospital de Gastroenterologia Udaondo

Capital Federal, Buenos Aires, Argentina

Fundacion Ars Medica

San Salvador de Jujuy, Jujuy Province, Argentina

Clinica Viedma

Viedma, Río Negro Province, Argentina

Centro Medico San Roque

San Miguel de Tucumán, Tucumán Province, Argentina

Fundacion Favaloro

Ciudad de Buenos Aires, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, Argentina

Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

San Juan, Argentina

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Austin Health

Heidelberg, Victoria, Australia

Landesklinikum Wr. Neustadt

Wiener Neustadt, Lower Austria, Austria

Universitätsklinikum Salzburg

Salzburg, Austria

KH der Barmherzigen Brüder Wien

Vienna, Austria

Cliniques universitaires Saint-Luc

Brussels, Brussels Capital, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, Belgium

Masarykuv onkologicky ustav

Brno, Brno-město, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni Nemocnice v Motole

Prague, Czechia

Aarhus Universitetshospital, Aarhus Sygehus

Aarhus C, Denmark

Odense Universitetshospital

Odense C, Denmark

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

CHU de Bordeaux Hop St ANDRE

Bordeaux, Gironde, France

CHU de Besancon Hopital Jean Minjoz

Besançon, France

Hôpital C. HURIEZ

Lille, France

CHRU de Montpellier-Hopital St Eloi

Montpellier, France

Centre Antoine-Lacassagne

Nice, France

Gustave Roussy

Villejuif, France

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Medizinische Hochschule Hanover

Hanover, Lower Saxony, Germany

HELIOS Klinikum Berlin-Buch

Berlin, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

Debreceni Egyetem Klinikai Kozpont Onkologiai Tanszek

Debrecen, Hajdú-Bihar, Hungary

Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

Budapest, Hungary

Arke Estudios Clinicos S.A. de C.V.

Mexico City, Mexico City, Mexico

Centro de Alta Especialidad Reumatologia Inv del Potosi SC

San Luis Potosí City, Mexico

Russian Scientific Center of Radiology and Surgical Technologies

Saint Petersburg, Sankt-Peterburg, Russia

Arkhangelsk Clinical Oncological Dispensary

Arkhangelsk, Russia

Blokhin Cancer Research Center

Moscow, Russia

Saint-Petersburg City Clinical Oncology Dispensary

Saint Petersburg, Russia

Asan Medical Center

Seoul, Korea, South Korea

Seoul National University Hospital

Seoul, Seoul, Korea, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Duran I Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Clínico Universitario de Valencia

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Clinico de San Carlos

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Skåne universitetssjukhus

Malmo, Sweden

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden

Chang Gung Memorial Hospital - Kaohsiung Branch

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng-Kung Uni. Hosp.

Tainan, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan, Taiwan

Baskent University Dr. Turgut Noyan Research and Training Center

Adana, Turkey (Türkiye)

Hacettepe University Faculty of Medicine

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Trakya University

Edirne, Turkey (Türkiye)

Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi

Istanbul, Turkey (Türkiye)

University College Hospital - London

London, Greater London, United Kingdom

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Hammersmith Hospital

Acton, London, United Kingdom

The Clatterbridge Cancer Centre

Bebbington, Merseyside, United Kingdom

Royal Marsden Hospital

Sutton, Surrey, United Kingdom