XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors
NCT ID: NCT00090025
Last Updated: 2009-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
248 participants
INTERVENTIONAL
2004-09-30
2006-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer
NCT05052099
A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases
NCT04338685
A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab
NCT05199285
A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer
NCT01911273
Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies
NCT06993025
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
becatecarin
becatecarin
becatecarin
Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
5-FU Plus Leucovorin (LV)
5-Fluorouracil (5-FU) Plus Leucovorin (LV)
5-Fluorouracil Plus Leucovorin
5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
becatecarin
Dose: 140 mg/m2 x day Mode of administration: i.v. via central venous catheter Duration of treatment: Days 1 through 5 of a 28 day cycle
5-Fluorouracil Plus Leucovorin
5-Fluorouracil (5-FU) + Leucovorin (LV) Dose: 375 mg /m2/day + 25 mg/m2/day Mode of administration: i.v. via central venous catheter or alternative i.v. administration.Duration of treatment: Days 1 through 5 of a 28 day cycle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 18 years or older
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
* Willing and able to sign informed consent
* Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide)
* Women of child-bearing age must have a negative pregnancy test
* Laboratory criteria
Exclusion Criteria
* Unstable angina, or class III or IV New York Heart Association heart disease
* Central nervous system metastases
* Uncontrolled diabetes mellitus
* Uncontrolled seizure disorder
* Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
* Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
* Pregnant or breast-feeding
* A known history of human immunodeficiency virus (HIV) infection
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Helsinn Healthcare SA
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pharma Company Sponsor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Afshin Dowlati, MD
Role: STUDY_CHAIR
Case Western Reserve University - Cleveland
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Long Beach VA Medical Center
Long Beach, California, United States
University of California, Irvine Medical Center
Orange, California, United States
Sharp Clinical Oncology Research
San Diego, California, United States
Pacific Hematology Oncology Associates
San Francisco, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Tampa General Hospital
Tampa, Florida, United States
Winship Cancer Institute, Emory University Hospital
Atlanta, Georgia, United States
Carle Clinic Association
Urbana, Illinois, United States
Medical Consultants, PC c/o Ball Cancer Center
Muncie, Indiana, United States
Oncology Associates
Cedar Rapids, Iowa, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
Josephine Ford Cancer Center at Henry Ford Health System
Detroit, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Oncology Care Center PLLC
Saint Joseph, Michigan, United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Queens Hospital Center
Jamaica, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
New York Medical College
Valhalla, New York, United States
Cancer Treatment and Research Center
Bismarck, North Dakota, United States
Gabrail Cancer Center
Canton, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Charleston Hematology Oncology, PA
Charleston, South Carolina, United States
The Sarah Cannon Cancer Center
Nashville, Tennessee, United States
Western Washington Oncology, Inc.
Lacey, Washington, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Universitair Ziekenhuis Gent
Ghent, , Belgium
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
London Regional Cancer Centre
London, Ontario, Canada
Ottawa Regional Cancer Centre
Ottawa, Ontario, Canada
Centre Hospitalier Universite de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU - Hospital Jean Minjoz
Besançon, , France
Hospital Ambroise Pare
Boulogne-Billancourt, , France
Centre Oscar Lambret
Lille, , France
Institut Gustave Roussy
Villejuif, , France
Charite Berlin der Humbold Universitat
Berlin, , Germany
Heinrich-Heine-Universitat-Dusseldorf
Düsseldorf, , Germany
Allgem. Krankenhaus St. Georg
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitätsklinikum Johannes Gutenberg
Mainz, , Germany
Technischen Universitat Munchen
Munich, , Germany
Klinikum Grosshadern der Ludwig Maximilians Universitaet
Munich, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Orszagos Onkologiai Intezet
Budapest, , Hungary
Centro di Riferimento Oncologico di Aviano
Aviano, , Italy
Ospidale Civile di Livorno
Livorno, , Italy
Policlinico Universitario di Udine
Udine, , Italy
Centrum Onkologii - Instytut im. Marii
Warsaw, , Poland
Cancer Research Center named after N.N. Blokhin, RAMS
Moscow, , Russia
Hospital Clinic i Provincial (Oncology Department)
Barcelona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Provincial de Pontevedra
Pontevedra, , Spain
Hospital Lozano Blesa
Zaragoza, , Spain
Leicester Royal Infirmary
Leicester, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
XL119-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.