NCT05251727

Assess Safety and Tolerability of ART-123 + FOLFOX + Bevacizumab in Metastatic Colorectal Cancer Patients

Double-blind, Placebo-controlled, Randomized, Dose-escalating, Multi-center, Phase 1 Study to Assess the Safety and Tolerability of ART-123 With Leucovorin/5-fluorouracil/Oxaliplatin and Bevacizumab in Metastatic Colorectal Cancer Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Veloxis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
DRUG	thrombomodulin alfa	Weight based dose of reconstituted treatment
DRUG	Placebo	Weight based dose of reconstituted treatment

Timeline

• Start date: 2022-03-24
• Primary completion: 2024-06-05
• Completion: 2024-06-05
• First posted: 2022-02-23
• Last updated: 2024-08-19

Locations

32 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study