Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Chemotherapy-induced Peripheral Neuropathy

In brief

To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab

Key facts

Study ID

NCT05251727

Run by

Veloxis Pharmaceuticals

People needed

77

Starts

2022-03-24

Expected to finish

2024-06-05

Last updated by the study team

2024-08-19

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• History of major hemorrhage
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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