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

NCT04492436 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-18

No results posted yet for this study

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

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DRUG

thrombomodulin alfa

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

DRUG

Placebo

Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle

Sponsors & Collaborators

  • Veloxis Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • David Fineberg, MD · Veloxis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2023-04-30
Completion
2024-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492436 on ClinicalTrials.gov