← Back to Search

Other

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

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
Select...
I am fully active or can carry out light work.
Select...
I have had nerve pain for over 6 months due to chemotherapy.
Select...
I have been diagnosed with cancer.
Select...
My bone marrow is functioning well.
Select...
I experience numbness, tingling, or pain in my fingers/hands or toes/feet.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently experiencing significant bleeding.
Select...
I have received chemotherapy that can cause nerve damage in the last year.
Select...
I have a history of heart problems.
Select...
I do not have severe nerve pain or damage.
Select...
I do not have any severe, uncontrolled infections.
Select...
My wounds heal slowly or poorly.
Select...
I am currently on or will start chemotherapy during the study.
Select...
I have type 1 or type 2 diabetes.
Select...
My family has a history of genetic nerve disorders.
Select...
I take more than 10 mg of prednisone or similar steroids daily.

Timeline

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

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 Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top