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BXQ-350 for Cancer-related Peripheral Neuropathy (RETRO Trial)

Q: How many participants are currently registered for the trial?

<p>Affirmative. Clinicaltrials.gov shows that this medical trial, which was initially posted on October 17th 2022, is currently searching for participants. The number of patients needed stands at 20 and the recruitment will take place in a single location.</p>

Q: Is participation in this medical experiment available to individuals at the present time?

<p>Affirmative. Clinicaltrials.gov confirms that this clinical trial, initially posted on October 17th 2022, is still actively searching for participants. This research requires 20 patients from one medical centre to be enrolled in the study.</p>

Phase < 1

Recruiting

Research Sponsored by Bexion Pharmaceuticals, Inc.

Eligibility Criteria Checklist

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

Must have

ECOG Performance Status of 0 or 1

Symptoms of CIPN persisting ≥6 months caused by prior exposure to oxaliplatin or taxane-based chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

RETRO Trial Summary

This trial will test if BXQ-350 can help cancer patients with chemotherapy-induced neuropathy by lessening symptoms and improving quality of life. The study is double-blinded, meaning neither the participants nor the researchers know who is receiving the experimental drug or the placebo.

Who is the study for?

This trial is for cancer patients aged 18 or older who have persistent symptoms of chemotherapy-induced peripheral neuropathy (CIPN) for at least 6 months after treatment with oxaliplatin or taxane. They should not have a history of genetic neuropathies, recent major surgery, cardiac issues, severe infections like HIV/Hepatitis B/C, active bleeding, diabetes, other clinical neuropathies or be on certain medications.Check my eligibility

What is being tested?

The study tests BXQ-350's effect on reducing the intensity and duration of CIPN to improve quality of life. Participants will undergo two blinded treatment cycles with BXQ-350/placebo randomly assigned, an optional open-label period with BXQ-350 and follow-up without blinding to monitor long-term effects.See study design

What are the potential side effects?

While specific side effects are not listed here, participants may experience reactions related to the components in BXQ-350 (SapC and DOPS). Common drug-related side effects could include allergic reactions, gastrointestinal issues or changes in blood counts.

RETRO Trial Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I have had nerve pain for over 6 months due to chemotherapy.

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I have been diagnosed with cancer.

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My bone marrow is functioning well.

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I experience numbness, tingling, or pain in my fingers/hands or toes/feet.

Select...

I am 18 years old or older.

RETRO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CIPN Assessment

Ceramide

Cytokine levels

+4 more

Secondary outcome measures

Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0

RETRO Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BXQ-350Experimental Treatment1 Intervention

BXQ-350 will be administered by IV infusion

Group II: PlaceboPlacebo Group1 Intervention

Placebo (0.9% normal saline) will be administered by IV infusion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BXQ-350

2016

Completed Phase 1

~90

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bexion Pharmaceuticals, Inc.Lead Sponsor

5 Previous Clinical Trials

362 Total Patients Enrolled

CTI Clinical Trial and Consulting ServicesOTHER

34 Previous Clinical Trials

3,715 Total Patients Enrolled

Media Library

BXQ-350 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05291286 — Phase < 1

Peripheral Neuropathy Research Study Groups: BXQ-350, Placebo

Peripheral Neuropathy Clinical Trial 2023: BXQ-350 Highlights & Side Effects. Trial Name: NCT05291286 — Phase < 1

BXQ-350 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05291286 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently registered for the trial?

"Affirmative. Clinicaltrials.gov shows that this medical trial, which was initially posted on October 17th 2022, is currently searching for participants. The number of patients needed stands at 20 and the recruitment will take place in a single location."

Answered by AI

Is participation in this medical experiment available to individuals at the present time?

"Affirmative. Clinicaltrials.gov confirms that this clinical trial, initially posted on October 17th 2022, is still actively searching for participants. This research requires 20 patients from one medical centre to be enrolled in the study."

Answered by AI

Who else is applying?

What site did they apply to?

Vanderbilt University Medical Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have peripheral neuropathy in my feet. A serious fall recently put me in the hospital. Neurologists diagnosed the cause as neuropathy. I would like to find out if BXQ-350 I can treat my condition and perhaps prevent further falls.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients

2022. "BXQ-350 Pharmacokinetic/Pharmacodynamic Study in Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05291286.

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