Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
NCT ID: NCT05251727
Last Updated: 2024-08-19
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
PHASE1
77 participants
INTERVENTIONAL
2022-03-24
2024-06-05
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.
Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
NCT01279681
Oxaliplatin, 5-FU and Leucovorin in Combination With Oral Capecitabine for Metastatic Colorectal Cancer
NCT00205322
Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer
NCT01718873
Valproic Acid in Combination With Bevacizumab and Oxaliplatin/Fluoropyrimidine Regimens in Patients With Ras-mutated Metastatic Colorectal Cancer
NCT04310176
Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colon Cancer That Cannot Be Removed By Surgery
NCT00321828
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
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lowest Dose
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)
thrombomodulin alfa
Weight based dose of reconstituted treatment
Low Dose
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
thrombomodulin alfa
Weight based dose of reconstituted treatment
Medium Dose
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
thrombomodulin alfa
Weight based dose of reconstituted treatment
High Dose
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
thrombomodulin alfa
Weight based dose of reconstituted treatment
Highest Dose
Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
thrombomodulin alfa
Weight based dose of reconstituted treatment
Placebo
Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"
Placebo
Weight based dose of reconstituted treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
thrombomodulin alfa
Weight based dose of reconstituted treatment
Placebo
Weight based dose of reconstituted treatment
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
* Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum
* ECOG performance status of 0 or 1
* The most recent laboratory findings (including for liver and kidney) within 14 days prior to randomization remain within acceptable ranges Willingness of the patient and the sexual partner to use a highly effective contraceptive method during the course of the study
* Able to sufficiently understand the clinical study and give written informed consent
Exclusion Criteria
* High risk of hemorrhage
* History of other malignancies
* Active ulcer
* Patients using anti-coagulants and fibrinolytic drugs
* Active Hepatitis B, or known HBs antigen positive
* Prior treatment history with thrombomodulin alfa
* Administration of another investigational medicinal product within 30 days prior to randomization
* Patient is pregnant (positive urine human chorionic gonadotropin) or breastfeeding or intends to get pregnant during the Treatment period
* Patients otherwise deemed as inappropriate to participate in the study by the Investigator
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Veloxis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Libbie McKenzie, MD FASN
Role: STUDY_DIRECTOR
Veloxis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beverly Hills Cancer Center
Beverly Hills, California, United States
UCLA Dept. of Medicine - Hematology/Oncology
Los Angeles, California, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States
Mid-Florida Hematology & Oncology Centers
Orange City, Florida, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, United States
American Oncology Partners, P.A.
Bethesda, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Site #115
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Nashville Oncology Associates, PC
Nashville, Tennessee, United States
Site #120
Dallas, Texas, United States
Site #114
Houston, Texas, United States
MultiCare Regional Cancer Center
Tacoma, Washington, United States
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okyama, Japan
NHO Kyushu Cancer Center
Fukuoka, , Japan
Gifu University Hospital
Gifu, , Japan
Kagawa University Hospital
Kita-gun, , Japan
Kitakyushubyoin Kitakyusyu General Hospital
Kitakyushu-shi, , Japan
Kumpukai Sano Hospital
Kobe, , Japan
NHO Shikoku Cancer Center
Matsuyama, , Japan
Kochi Medical School Hospital
Nankoku-shi, , Japan
NHO Osaka National Hospital
Osaka, , Japan
Osaka General Medical Center
Osaka, , Japan
Tonan Hospital
Sapporo, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
University of Tsukuba Hospital
Tsukuba, , Japan
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.
ART-123.PN101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.