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BXQ-350 for Cancer-related Peripheral Neuropathy (RETRO Trial)
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 belowSelect...
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.
RETRO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreSecondary 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
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had nerve pain for over 6 months due to chemotherapy.I am fully active or can carry out light work.I have had nerve pain for over 6 months due to chemotherapy.I have been diagnosed with cancer.My liver is working well.I am currently experiencing significant bleeding.I have received chemotherapy that can cause nerve damage in the last year.I have a history of heart problems.I do not have severe nerve pain or damage.I do not have any severe, uncontrolled infections.My bone marrow is functioning well.My wounds heal slowly or poorly.I experience numbness, tingling, or pain in my fingers/hands or toes/feet.I am currently on or will start chemotherapy during the study.I can sign and understand the consent form.I am using birth control as per my local laws.My kidneys are working well.I have type 1 or type 2 diabetes.I am 18 years old or older.My family has a history of genetic nerve disorders.I have adjusted my neuropathy medication within the last 28 days.I take more than 10 mg of prednisone or similar steroids daily.
Research Study Groups:
This trial has the following groups:- Group 1: BXQ-350
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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