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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Biliary Tract Cancer, Metastatic Cancer, Advanced Cancer

In brief

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.

Key facts

Study ID

NCT02711553

Run by

Eli Lilly and Company

People needed

309

Starts

2016-05-19

Expected to finish

2026-12-01

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• The University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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