Status:
TERMINATED
Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
Lead Sponsor:
Veloxis Pharmaceuticals
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
Detailed Description
To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2024
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05251727
Start Date
March 24 2022
End Date
June 5 2024
Last Update
August 19 2024
Active Locations (32)
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1
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90210
2
UCLA Dept. of Medicine - Hematology/Oncology
Los Angeles, California, United States, 90095
3
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, United States, 06360
4
Mid-Florida Hematology & Oncology Centers
Orange City, Florida, United States, 32763