Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients
Chemotherapy-induced Peripheral Neuropathy
About this trial
This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Beverly Hills Cancer CenterRecruiting
- UCLA Dept. of Medicine - Hematology/OncologyRecruiting
- Eastern Connecticut Hematology & Oncology AssociatesRecruiting
- Mid-Florida Hematology & Oncology CentersRecruiting
- Horizon Oncology Research, Inc.Recruiting
- American Oncology Partners of MarylandRecruiting
- St. Vincent Frontier Cancer CenterRecruiting
- Englewood Hospital and Medical CenterRecruiting
- Site #115
- Memorial Sloan Kettering Cancer CenterRecruiting
- Oregon Health & Science UniversityRecruiting
- Prisma Health Cancer InstituteRecruiting
- Nashville Oncology Associates, PCRecruiting
- Site #120
- Site #114
- MultiCare Regional Cancer CenterRecruiting
- NHO Kyushu Cancer CenterRecruiting
- Gifu University HospitalRecruiting
- Kagawa University HospitalRecruiting
- Kitakyushubyoin Kitakyusyu General HospitalRecruiting
- Kumpukai Sano HospitalRecruiting
- NHO Shikoku Cancer CenterRecruiting
- Kochi Medical School HospitalRecruiting
- NHO Osaka National HospitalRecruiting
- Osaka General Medical CenterRecruiting
- Tonan HospitalRecruiting
- Shizuoka Cancer CenterRecruiting
- University of Tsukuba HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Lowest Dose
Low Dose
Medium Dose
High Dose
Highest Dose
Placebo
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)
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)"
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)"
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)"
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)"
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)"