Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Veloxis Pharmaceuticals
To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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