Oxaliplatin-Induced Peripheral Neuropathy
Conditions
Interventions
Sponsors
Tawara Shunsuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 years of age or older at the time of signing the ICF - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - The most recent laboratory findings (including for liver and kidney) within 14 days prior to the planned randomization remain within acceptable ranges - Able to sufficiently understand the clinical study and give informed consent
Exclusion criteria
Exclusion criteria: - Symptomatic peripheral neuropathy or documented history of peripheral neuropathy in medical record - Patient using anti-coagulants or fibrinolytic drugs - Active hepatitis B, or known hepatitis B surface antigen positive - Prior treatment history with thrombomodulin alfa - Administration of another investigational medicinal product within 30 days prior to randomization - Patient is pregnant (urine human chorionic gonadotropin or serum human chorionic gonadotropin positive) or breastfeeding or intends to get pregnant during the treatment period. If the patient or the patient's female partner is a fertile woman, the patient who cannot agree to appropriate contraception - Patients otherwise deemed as inappropriate to participate in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline in the total FACT/GOG-NTX4 score | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who developed Grade 2 or higher peripheral sensory neuropathy (Common Terminology Criteria for Adverse Events: CTCAE) | — |
Contacts
Public ContactContact for Clinical Trial Information
ASAHI KASEI THERAPEUTICS CORPORATION
Outcome results
None listed