A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
NCT ID: NCT02711553
Last Updated: 2025-08-03
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
309 participants
INTERVENTIONAL
2016-05-19
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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8 mg/kg Ramucirumab + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
Participants received 8 mg/kg ramucirumab plus 25 mg/square meter (mg/m²) cisplatin and 1000 mg/m² gemcitabine intravenously (IV) on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for ramucirumab therapy).
Ramucirumab
Administered IV
Cisplatin
Administered IV
Gemcitabine
Administered IV
Placebo IV + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
Participants received placebo (indistinguishable and equivalent volume to ramucirumab) plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
Cisplatin
Administered IV
Gemcitabine
Administered IV
Placebo IV
Administered IV
80 mg Merestinib + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
Participants received 80 mg merestinib orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days (1 cycle). Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for merestinib therapy).
Merestinib
Administered orally
Cisplatin
Administered IV
Gemcitabine
Administered IV
Placebo Oral + 25 mg/m² Cisplatin + 1000 mg/m² Gemcitabine
Participants received placebo (indistinguishable to merestinib) orally each day, plus 25 mg/m² cisplatin and 1000 mg/m² gemcitabine IV on Days 1 and 8, every 21 days. Participants may continue on study drug for up to 8 cycles (for cisplatin and gemcitabine therapy) or until disease progression, unacceptable toxicity, or other withdrawal criterion is met (for placebo therapy).
Cisplatin
Administered IV
Gemcitabine
Administered IV
Placebo Oral
Administered orally
Interventions
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Ramucirumab
Administered IV
Merestinib
Administered orally
Cisplatin
Administered IV
Gemcitabine
Administered IV
Placebo Oral
Administered orally
Placebo IV
Administered IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a histologically or cytologically confirmed diagnosis of non-resectable, recurrent, or metastatic biliary tract adenocarcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or Ampulla of Vater) .
* Have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
* Have adequate biliary drainage.
* Have adequate organ function.
* Males and females are sterile, postmenopausal, or compliant with a highly effective contraceptive method.
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose.
* Are willing to provide blood/serum/plasma and tumor tissue samples for research purposes. Submission of blood/serum/plasma and tumor tissue samples is mandatory for participation in this study, unless restricted per local regulations.
Exclusion Criteria
* Have a history of or have current hepatic encephalopathy of any grade, or ascites of Grade \>1, or cirrhosis with Child-Pugh Stage B or higher.
* Have ongoing or recent (≤6 months) hepatorenal syndrome.
* Have had a major surgical procedure or significant traumatic injury including nonhealing wound, peptic ulcer, or bone fracture ≤28 days prior to randomization.
* Anticipate having a major surgical procedure during the course of the study.
* Has documented brain metastases, leptomeningeal disease, or uncontrolled spinal cord compression.
* Within 6 months prior to randomization, have had any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
* Have an uncontrolled arterial hypertension with systolic blood pressure ≥150 or diastolic blood pressure ≥90 millimeters of mercury (mm Hg) despite standard medical management.
* Have a previous malignancy within 5 years of study entry or a concurrent malignancy.
* Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
* Have a known allergy or hypersensitivity reaction to any of the treatment components.
* Have a history of uncontrolled hereditary or acquired thrombotic disorder.
* Have uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases or secondary effects of cancer that induce a high medical risk and/or make assessment of survival uncertain.
* Have mixed hepatocellular biliary tract cancer histology.
* Have a corrected QT interval \>470 milliseconds as calculated by the Fridericia equation.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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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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 City, , 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
Countries
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References
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Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer
Other Identifiers
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I3O-MC-JSBF
Identifier Type: OTHER
Identifier Source: secondary_id
2015-004699-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16329
Identifier Type: -
Identifier Source: org_study_id
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