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)
Progression Free Survival (PFS) — Randomization to Progressive Disease or Death from Any Cause (Up To 20 Months) PFS time was measured from the date of randomization until the first radiographic documentation of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Trial sites (82)
Facility
City
Region
Status
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
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.
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