Chemotherapy-induced Peripheral Neuropathy
Conditions
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
Interventions
Weight based dose of reconstituted treatment
DRUGPlacebo
Weight based dose of reconstituted treatment
Sponsors
Veloxis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants with Anti-ART-123 Antibodies | 6 weeks | 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 |
| Number and Percentage of Participants with Abnormal Serum Chemistry Results | 6 weeks | 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) |
| Number and Percentage of Participants with Abnormal Coagulation Panel Results | 6 weeks | Descriptive statistics will summarize the following by cohort: international normalized ratio (INR), activated partial thromboplastin time (APTT) |
| Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results | 6 weeks | Qualitative summary of the following by cohort: protein, glucose, and occult blood |
| Number and Percentage of Participants with Abnormal Vital Signs | 6 weeks | Descriptive statistics will summarize the following by cohort: body temperature, pulse, and blood pressure |
| Number and Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | 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 experiencing one or more adverse events which occurred or worsened in severity after the start of the first dose of investigational medicinal product (IMP) |
| Number and Percentage of Participants with Serious TEAEs | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks | 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 |
| Number and Percentage of Participants with TEAEs Leading to Death | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks | Number and percentage of participants with TEAEs that resulted in death |
| Number and Percentage of Participants with TEAEs Leading to IMP Discontinuation | 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 TEAEs that lead to discontinuation of IMP |
| Number and Percentage of Participants with Bleeding Events | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks | Number and percentage of participants experiencing bleeding events |
| Number and Percentage of Participants with Serious Bleeding Events | From start of first IMP dose (Cycle 1, Day 1) through EOT visit; planned for 6 weeks | Number and percentage of participants with bleeding events that represent serious adverse events |
| Number and Percentage of Participants with Dose Limiting Toxicity (DLT) | 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 experiencing DLT |
| Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results | 6 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of 5-fluorouracil (5-FU) | Cycle 1, Day 1 (each cycle is 14 days) | Plasma concentrations of 5-FU associated with Cycle 1 dosing (each cycle is 14 days) |
| Plasma Concentrations of Oxaliplatin | Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days) | Plasma concentrations of oxaliplatin associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days) |
| Serum Concentrations of Bevacizumab | Cycle 1, Day 1 and Cycle 3, Day 1 (each cycle is 14 days) | Serum concentrations of bevacizumab associated with Cycle 1 and Cycle 3 dosing (each cycle is 14 days) |
| Plasma Concentrations of Thrombomodulin | Cycle 1, Day 1 (each cycle is 14 days) | Plasma concentrations of thrombomodulin associated with Cycle 1 dosing (each cycle is 14 days) |
Countries
Japan, United States
Outcome results
None listed