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Clinical Trials in the UK / NCT02711553
Active, not recruiting Phase 2

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

NCT02711553 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2016-05-19
Last updated
2026-07-22

Condition(s) studied

Biliary Tract CancerMetastatic CancerAdvanced Cancer

Investigational drug(s) / intervention(s)

RamucirumabMerestinibCisplatinGemcitabinePlacebo OralPlacebo IV

Ramucirumab: Administered IV

Merestinib: Administered orally

Cisplatin: Administered IV

Gemcitabine: Administered IV

Placebo Oral: Administered orally

Placebo IV: Administered IV

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Have an Eastern Cooperative Oncology Group performance status of 0 or 1. * 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: * Previous systemic therapy for locally advanced or metastatic disease is not allowed. * 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.

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
The University of Arizona Cancer Center Tucson Arizona
UCSF Medical Center at Mission Bay San Francisco California
Georgetown University Medical Center Washington D.C. District of Columbia
University of Florida School of Medicine Gainesville Florida
Karmanos Cancer Institute Detroit Michigan
Washington University Medical School City of Saint Peters Missouri
Washington University Medical School Creve Coeur Missouri
Washington University Medical School St Louis Missouri
Washington University Medical School St Louis Missouri
Thomas Jefferson University Philadelphia Pennsylvania
Fox Chase Cancer Center Philadelphia Pennsylvania
Florida Cancer Specialists Nashville Tennessee
Tennessee Oncology PLLC Nashville Tennessee
Alexander Fleming CABA BS
Hospital de Gastroenterologia Udaondo Capital Federal Buenos Aires
Fundacion Ars Medica San Salvador de Jujuy Jujuy Province
Clinica Viedma Viedma Río Negro Province
Centro Medico San Roque San Miguel de Tucumán Tucumán Province
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
Royal Adelaide Hospital Adelaide South Australia
Austin Health Heidelberg Victoria
Landesklinikum Wr. Neustadt Wiener Neustadt Lower Austria
Universitätsklinikum Salzburg Salzburg Austria
KH der Barmherzigen Brüder Wien Vienna Austria
Cliniques universitaires Saint-Luc Brussels Brussels Capital
Universitair Ziekenhuis Gent Ghent Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg Leuven Belgium
Masarykuv onkologicky ustav Brno Brno-město
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
CHU de Bordeaux Hop St ANDRE Bordeaux Gironde
CHU de Besancon Hopital Jean Minjoz Besançon France
Hôpital C. HURIEZ Lille France
CHRU de Montpellier-Hopital St Eloi Montpellier France

+ 42 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02711553 on ClinicalTrials.gov ↗ ← All trials in the UK