Oxaliplatin-Induced Peripheral Neuropathy
Conditions
Interventions
Sponsors
Tawara Shunsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years of age or older - Metastatic colorectal cancer with intact primary tumor (IPT); 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
Exclusion criteria: - History of major hemorrhage - High risk of hemorrhage - 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 |
|---|---|
| Safety endpoints: AEs, Bleeding event, DLTs, Laboratory tests, Vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse rate) , Anti-ART-123 antibodies and neutralizing antibodies PK endpoints: Plasma concentration of thrombomodulin | — |
Contacts
Public ContactContact for Clinical Trial Information
ASAHI KASEI THERAPEUTICS CORPORATION
Outcome results
None listed