18 Participants NeededMy employer runs this trial

SIR2501 for Peripheral Neuropathy

Recruiting at 4 trial locations
MM
Overseen ByMedical Monitor
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sironax USA, Inc.
Must be taking: Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, SIR2501, to determine its effectiveness in preventing chemotherapy-induced peripheral neuropathy (CIPN). CIPN can cause tingling, numbness, or pain in the hands and feet and often affects individuals undergoing chemotherapy for solid tumors. The study will assess the safety and tolerability of SIR2501 by testing three different doses. Adults with solid tumors who are about to start paclitaxel-based chemotherapy may qualify, provided they do not already have peripheral neuropathy or other conditions that could impact the study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use medications known to reduce chemotherapy-induced peripheral neuropathy, and you cannot have conditions or take medications that interfere with neuropathy assessment.

Is there any evidence suggesting that SIR2501 is likely to be safe for humans?

Research suggests that SIR2501 might be safe for humans. People who have taken similar treatments in the past have generally tolerated these drugs well. Reports show no safety concerns, and earlier studies noted no major side effects. Additionally, SIR2501 targets a protein that helps prevent nerve damage, and lab tests have shown it protects nerves. While this indicates potential safety, further research is needed to confirm these findings.12345

Why do researchers think this study treatment might be promising for peripheral neuropathy?

Most treatments for peripheral neuropathy focus on managing symptoms through medications like gabapentin or duloxetine, which often work by altering nerve signals. But SIR2501 is different because it targets the underlying nerve damage itself. Researchers are excited about SIR2501 because it uses a novel mechanism that aims to repair and regenerate damaged nerves, potentially addressing the root cause rather than just alleviating symptoms. This could mean more effective, long-term relief for patients suffering from this condition.

What evidence suggests that SIR2501 might be an effective treatment for peripheral neuropathy?

Research has shown that SIR2501 might help with chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of chemotherapy with no effective treatments currently available. This makes CIPN a critical unmet medical need. Early findings suggest that SIR2501 could help manage CIPN symptoms. Although limited data exists on its effectiveness in humans, SIR2501 might protect nerve cells from chemotherapy-induced damage. This protection could reduce symptoms like tingling, numbness, or pain in the hands and feet for patients undergoing treatment.678910

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors who are about to start paclitaxel-based chemotherapy. Participants should be generally healthy aside from their cancer and able to follow study procedures.

Inclusion Criteria

I am 18 or older and have been diagnosed with a solid tumor.
I am able to care for myself and perform daily activities.
I am scheduled to receive paclitaxel-based chemotherapy.

Exclusion Criteria

Significant medical conditions that may increase study risk
I have nerve damage causing numbness or tingling in my hands or feet.
I have received chemotherapy that can affect the nerves.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

SIR2501 is administered to patients receiving paclitaxel-based chemotherapy to evaluate safety, tolerability, and pharmacokinetics

Duration of paclitaxel treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and neuropathy

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • SIR2501

Trial Overview

The study tests SIR2501, given alongside standard paclitaxel chemotherapy, to see if it is safe and can help prevent or reduce nerve damage (peripheral neuropathy) caused by the chemo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: 60 mgExperimental Treatment1 Intervention
Group II: 45 mgExperimental Treatment1 Intervention
Group III: 30 mgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sironax USA, Inc.

Lead Sponsor

Trials
1
Recruited
50+

Citations

First Patient Dosed in Chemotherapy Induced Peripheral ...

CIPN is one of the most frequent chemotherapy side-effects but has no effective therapies and is considered a critical unmet medical need. In ...

Number of ongoing Clinical Trials (for drugs) involving ...

Methycobal Tablet is indicated for the treatment of peripheral neuropathy and injection is used for the treatment of peripheral neuropathy and megaloblastic ...

Chemotherapy-induced damage - Drugs, Targets, Patents

... Peripheral Neuropathy in Breast Cancer Patients Receiving Chemotherapy: a Randomized Controlled Trial. 100 Clinical Results associated with Chemotherapy ...

Comparison of neuropathy scoring system... | Clinical Trial

View detailed information about this clinical trial on MedPath Trial.

http://sfxhosted.exlibrisgroup.com/hfhs?sid=Entrez...

No information is available for this page.

Therapeutic safety implications of SARM1 active site ...

Several preclinical studies have shown that pharmacological SARM1 inhibition can protect axons in injury-or chemotherapy-induced neuropathy models

Pharmacological SARM1 inhibition protects axon structure ...

Chemotherapy-induced peripheral neuropathy (CIPN) is a major cause of morbidity and the main cause of dose reductions and discontinuations in ...

Efficacy and Safety Study of Halneuron in the ... - ICH GCP

A randomized study to determine safety and efficacy of a series of subcutaneous (SC) injections of HAL in patients with CINP, compared to ...

Efficacy of SINR in Diabetic Neuropathy | PDF

The treatment was found to be safe and did not raise safety concerns or induce hypoglycemia episodes.

https://clinicaltrials.takeda.com/study-detail/5f6...