A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of ART-123 on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal cancer who receive oxaliplatin-containing chemotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asahi Kasei Pharma America Corporation; Veloxis Pharmaceuticals

Criteria

Inclusion Criteria:

• 18 years of age or older

• Unresectable 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:

• Prior treatment history with nerve toxic chemotherapeutic agent

• Peripheral neuropathy or central nervous system damage

• Psychiatric disorder

• 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