Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
Reason given: Business Decision
Key facts
- Where
- Bethesda, Beverly Hills, Billings, Boston, Dallas, Detroit, Englewood, Greenville, Hackensack, Houston, Lafayette, Los Angeles, Nashville, New York, Norwich, Orange City, Portland, and Tacoma, United StatesSee the 18 sites
- Phase
- Phase 1
Where in United States
- American Oncology Partners, P.A.Bethesda, United StatesNo longer taking part
- Beverly Hills Cancer CenterBeverly Hills, United StatesNo longer taking part
- St. Vincent Frontier Cancer CenterBillings, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- DallasDallas, United StatesNo longer taking part
- Henry Ford Health SystemDetroit, United StatesNo longer taking part
- Englewood Hospital and Medical CenterEnglewood, United StatesNo longer taking part
- Prisma Health Cancer InstituteGreenville, United StatesNo longer taking part
- HackensackHackensack, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- Horizon Oncology Research, Inc.Lafayette, United StatesNo longer taking part
- UCLA Dept. of Medicine - Hematology/OncologyLos Angeles, United StatesNo longer taking part
- Nashville Oncology Associates PCNashville, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- Eastern Connecticut Hematology & Oncology AssociatesNorwich, United StatesNo longer taking part
- Mid-Florida Hematology & Oncology CentersOrange City, United StatesNo longer taking part
- Oregon Health Science UniversityPortland, United StatesNo longer taking part
- MultiCare Regional Cancer CenterTacoma, United StatesNo longer taking part
Trial details
- Who runs it
- Veloxis Pharmaceuticals
- Trial code
- NCT05251727
- Record updated
- 19 August 2024
- Original description
To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumabRead full original descriptionShow less
Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients
To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
Inclusion: 18 years of age or older; 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: Patients using anti-coagulants and fibrinolytic drugs; Prior treatment history with thrombomodulin alfa; Administration of another investigational medicinal product within 30 days prior to randomization; History of major hemorrhage; High risk of hemorrhage; History of other malignancies; Active ulcer; Active Hepatitis B, or known HBs antigen positive; 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.