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

Phase < 1

Waitlist Available

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

Must not have

Active clinically significant bleed

Received chemotherapy known to cause CIPN in the last 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

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.

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.

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.

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.

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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 am currently experiencing significant bleeding.

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I have received chemotherapy that can cause nerve damage in the last year.

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I have a history of heart problems.

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I do not have severe nerve pain or damage.

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I do not have any severe, uncontrolled infections.

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My wounds heal slowly or poorly.

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I am currently on or will start chemotherapy during the study.

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I have type 1 or type 2 diabetes.

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My family has a history of genetic nerve disorders.

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I take more than 10 mg of prednisone or similar steroids daily.

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

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

Primary study objectives

CIPN Assessment

Ceramide

Cytokine levels

+4 more

Secondary study objectives

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

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 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bexion Pharmaceuticals, Inc.Lead Sponsor

5 Previous Clinical Trials

350 Total Patients Enrolled

CTI Clinical Trial and Consulting ServicesOTHER

35 Previous Clinical Trials

3,769 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

~7 spots leftby Sep 2025

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