Status:
WITHDRAWN
A Trial Measuring ART-123 Ability to Prevent Sensory Neuropathy in Unresectable mCRC Subjects w/Oxaliplatin-based Chemo
Lead Sponsor:
Veloxis Pharmaceuticals
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 oxaliplati...
Detailed Description
To compare the efficacy and safety of ART-123 (low and high dose) to placebo on sensory symptoms of oxaliplatin-induced peripheral neuropathy (OIPN) in patients with unresectable metastatic colorectal...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04492436
Start Date
October 1 2021
End Date
July 1 2024
Last Update
February 18 2022
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