To evaluate the safety and tolerability of ART-123 in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
To compare the safety and tolerability of ART-123 to placebo in patients with metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy and bevacizumab
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
77
Weight based dose of reconstituted treatment
Weight based dose of reconstituted treatment
Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Number and percentage of participants experiencing one or more adverse events which occurred or worsened in severity after the start of the first dose of investigational medicinal product (IMP)
Time frame: From start of first IMP dose (Cycle 1, Day 1) through End of Treatment (EOT) visit; planned for 6 weeks
Number and Percentage of Participants with Serious TEAEs
Number and percentage of participants experiencing one or more serious adverse events which occurred or worsened in severity after the start of the first dose of IMP
Time frame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Number and Percentage of Participants with TEAEs Leading to Death
Number and percentage of participants with TEAEs that resulted in death
Time frame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation
Number and percentage of participants with TEAEs that lead to discontinuation of IMP
Time frame: From start of first IMP dose (Cycle 1, Day 1) through planned third IMP dose; planned for 4 weeks
Number and Percentage of Participants with Bleeding Events
Number and percentage of participants experiencing bleeding events
Time frame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
Number and Percentage of Participants with Serious Bleeding Events
Number and percentage of participants with bleeding events that represent serious adverse events
Time frame: From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks
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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
...and 22 more locations
Number and Percentage of Participants with Dose Limiting Toxicity (DLT)
Number and percentage of participants experiencing DLT
Time frame: From start of first IMP dose (Cycle 1, Day 1) until the start of the third IMP dose; planned for 4 weeks
Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results
Descriptive statistics will summarize the following by cohort: red blood cell count, hemoglobin, hematocrit, white blood cell count, white blood cell differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils), and platelet count
Time frame: 6 weeks
Number and Percentage of Participants with Abnormal Serum Chemistry Results
Descriptive statistics will summarize the following by cohort: aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, lactate dehydrogenase, total bilirubin, total protein, albumin, blood urea nitrogen, creatinine, glucose, and electrolytes (sodium, potassium, chloride)
Time frame: 6 weeks
Number and Percentage of Participants with Abnormal Coagulation Panel Results
Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT)
Time frame: 6 weeks
Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results
Qualitative summary of the following by cohort: protein, glucose, and occult blood
Time frame: 6 weeks
Number and Percentage of Participants with Abnormal Vital Signs
Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure
Time frame: 6 weeks
Number and Percentage of Participants with Anti-ART-123 Antibodies
Number and Percentage of Participants with detectable anti-ART-123 antibodies; samples testing positive for anti-ART-123 antibodies will be tested for the presence of neutralizing antibodies
Time frame: 6 weeks
Plasma Concentrations of Thrombomodulin
Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days)
Time frame: Cycle 1, Day 1 (each cycle is 14 days)
Plasma Concentrations of 5-fluorouracil (5-FU)
Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days)
Time frame: Cycle 1, Day 1 (each cycle is 14 days)
Plasma Concentrations of Oxaliplatin
Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)
Time frame: Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)
Serum Concentrations of Bevacizumab
Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days)
Time frame: Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days)