What side effects are associated with this type of intervention?

Common treatments for peripheral neuropathy include antiepileptic drugs (such as gabapentin, pregabalin, and carbamazepine), topical agents (like lidocaine patches), and intravenous immunoglobulin (IVIG). Known side effects of these treatments can vary. Antiepileptic drugs may cause dizziness, drowsiness, and peripheral edema. Topical agents like lidocaine patches are generally well-tolerated but can cause localized skin reactions. IVIG treatment can lead to headaches, fever, chills, and in rare cases, more severe reactions such as thromboembolic events. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

The FDA has approved several treatments for peripheral neuropathy, though none specifically modulate the coagulation pathway like ART-123. Commonly approved drugs include antiepileptic medications such as gabapentin and pregabalin, which are used to manage neuropathic pain. Immunosuppressive agents and intravenous immunoglobulins are also used, particularly for conditions like multifocal motor neuropathy. Monoclonal antibodies like ipilimumab and pembrolizumab have been associated with peripheral neuropathy as an adverse effect, but are not primary treatments for the condition.

What other types of research exist?

Promising novel alternatives to ART-123 for peripheral neuropathy patients include Tafamidis Meglumine, which is used for hereditary transthyretin amyloidosis with peripheral polyneuropathy, and plasma exchange therapy, which has shown efficacy in chronic inflammatory demyelinating polyneuropathy. Additionally, ongoing research into the use of gene therapy and novel pharmacological agents targeting specific neuropathic pathways may offer new treatment options in the near future.

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ART-123 + Chemotherapy for Colorectal Cancer

Phase 1

Waitlist Available

Research Sponsored by Veloxis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Metastatic colorectal cancer; pathologically confirmed adenocarcinoma of the colon or rectum

18 years of age or older

Must not have

Active ulcer

High risk of hemorrhage

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)

Summary

This trial is testing ART-123 to see if it can help patients with advanced colorectal cancer who are already receiving specific chemotherapy drugs. The goal is to find out if ART-123 can make their treatment safer or more tolerable.

Who is the study for?

This trial is for adults over 18 with metastatic colorectal cancer and an ECOG performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants must have normal recent liver and kidney tests, agree to use effective contraception, and be able to consent. Excluded are those with a high bleeding risk, other cancers, active ulcers, hepatitis B, prior thrombomodulin alfa treatment or recent investigational drug use.

What is being tested?

The study is testing the safety of ART-123 when added to FOLFOX (a type of chemotherapy) plus Bevacizumab in treating metastatic colorectal cancer. Patients will either receive ART-123 or a placebo alongside their standard chemotherapy regimen to compare outcomes.

What are the potential side effects?

Potential side effects may include increased risk of bleeding due to ART-123's effect on blood clotting; common chemo-related issues like nausea, fatigue, neuropathy; and Bevacizumab's risks such as hypertension and rare severe bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of colon or rectum cancer that has spread to other parts.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active ulcer.

Select...

I am at high risk for bleeding.

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I have active Hepatitis B or tested positive for HBs antigen.

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I have had cancer before.

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I have had a major bleeding event in the past.

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I have been treated with thrombomodulin alfa before.

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I am currently taking blood thinners or clot-dissolving drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1, day 1 and cycle 3, day 1 (each cycle is 14 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number and Percentage of Participants with Abnormal Coagulation Panel Results

Number and Percentage of Participants with Abnormal Complete Blood Count (CBC) Results

Number and Percentage of Participants with Abnormal Qualitative Urinalysis Results

+10 more

Secondary study objectives

Plasma Concentrations of 5-fluorouracil (5-FU)

Plasma Concentrations of Oxaliplatin

Plasma Concentrations of Thrombomodulin

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Medium DoseExperimental Treatment1 Intervention

Lyophilized ART-123 reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

Group II: Lowest DoseExperimental Treatment1 Intervention

Group III: Low DoseExperimental Treatment1 Intervention

Group IV: Highest DoseExperimental Treatment1 Intervention

Group V: High DoseExperimental Treatment1 Intervention

Group VI: PlaceboPlacebo Group1 Intervention

Lyophilized placebo reconstituted with sterile water for injection and administered by intravenous infusion over approximately 30 minutes prior to chemotherapy on Day 1 of cycle (for up to 3 cycles including bevacizumab)"

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Peripheral neuropathy treatments often target the underlying causes or symptoms of nerve damage. Common treatments include medications like anticonvulsants (e.g., gabapentin, pregabalin) and antidepressants (e.g., amitriptyline, duloxetine) which modulate nerve pain by altering neurotransmitter levels. Topical treatments like capsaicin and lidocaine patches provide localized pain relief by desensitizing pain receptors. For chemotherapy-induced peripheral neuropathy, agents like menthol and capsaicin patches are used to alleviate symptoms. ART-123, a recombinant thrombomodulin, modulates the coagulation pathway, which could potentially reduce inflammation and microvascular complications, thereby protecting nerve function. Understanding these mechanisms is crucial for peripheral neuropathy patients as it helps in selecting appropriate treatments that target specific pathways involved in their condition, potentially improving outcomes and quality of life.

Status of current clinical trials in diabetic polyneuropathy.

Find a Location

Who is running the clinical trial?

Veloxis PharmaceuticalsLead Sponsor

41 Previous Clinical Trials

2,993 Total Patients Enrolled

Aimee Liu, MD PhDStudy DirectorVeloxis Pharmaceuticals

Shailesh G. Chavan, MDStudy DirectorVeloxis Pharmaceuticals

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

thrombomodulin alfa Clinical Trial Eligibility Overview. Trial Name: NCT05251727 — Phase 1

Peripheral Neuropathy Research Study Groups: Placebo, Lowest Dose, High Dose, Highest Dose, Low Dose, Medium Dose

Peripheral Neuropathy Clinical Trial 2023: thrombomodulin alfa Highlights & Side Effects. Trial Name: NCT05251727 — Phase 1

thrombomodulin alfa 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251727 — Phase 1

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