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BXQ-350 for Colorectal Cancer (ASIST Trial)
Phase 1 & 2
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
Acceptable renal function: Creatinine clearance ≥ 50 mL/minute, Urine dipstick protein < 1 + (30 - 70 mg/dL), Urine protein/creatinine ratio < 1, 24-hour urine protein < 1g/24 hours
ECOG Performance Status of 0 or 1
Must not have
Family history of genetic/familial neuropathy
Concurrent malignancy within the past 5 years expected to alter life expectancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Summary
This trialwill test a drug to treat colon/rectal cancer that could reduce oxaliplatin-induced neurotoxicity and allow a full dose of mFOLFOX7 and bevacizumab.
Who is the study for?
Adults over 18 with newly diagnosed Stage IV metastatic adenocarcinoma of the colon/rectum, measurable disease, life expectancy >3 months, and good performance status. They must have proper organ function and agree to use effective contraception. Excluded are those with certain other cancers, diabetes, specific heart conditions, uncontrolled infections or prior treatments that could interfere.
What is being tested?
The trial is testing BXQ-350 combined with mFOLFOX7 chemotherapy and bevacizumab against a placebo combination in patients with colorectal cancer. The first stage determines the safe dose of BXQ-350; the second stage tests its effectiveness at that dose compared to placebo.
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like nausea, fatigue, risk of infection due to low blood counts. There's also a focus on whether BXQ-350 reduces nerve damage from treatment (neuropathy). Specific side effects related to BXQ-350 aren't listed but would be monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is good, with acceptable creatinine clearance and protein levels.
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I am fully active or can carry out light work.
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My blood tests show normal white blood cells, platelets, and hemoglobin levels.
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I am 18 years old or older.
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I have been diagnosed with advanced colon or rectal cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My family has a history of genetic nerve disorders.
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I have had another cancer in the last 5 years that could shorten my life.
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I have previously been treated with chemotherapy that affects the nerves or drugs targeting blood vessel growth.
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My advanced colorectal cancer is MSI-high or has DNA repair issues.
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I have been diagnosed with reversible brain swelling.
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I have type 1 or type 2 diabetes.
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I do not have severe nerve pain or damage.
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I am currently being treated for nerve damage in my hands or feet.
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I have an active hole or abnormal connection in my digestive tract.
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I have had heart problems, like a heart attack or heart failure.
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I do not have any severe, uncontrolled infections like HIV or Hepatitis B/C.
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I have not had major surgery in the last 4 weeks.
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My high blood pressure is not well-controlled despite taking medication.
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I have issues with wounds not healing well or bleeding problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v5.0
Objective Response Rate (ORR)
Recommended Phase 2 Dose
Secondary study objectives
CIPN Assessment
Disease Control Rate (DCR)
Duration of Response (DoR)
+5 moreTrial 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 (Stage 2 only)
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
176 Total Patients Enrolled
ICON plcIndustry Sponsor
85 Previous Clinical Trials
28,281 Total Patients Enrolled
CTI Clinical Trial and Consulting ServicesOTHER
35 Previous Clinical Trials
3,595 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My family has a history of genetic nerve disorders.I have had another cancer in the last 5 years that could shorten my life.My kidney function is good, with acceptable creatinine clearance and protein levels.I have previously been treated with chemotherapy that affects the nerves or drugs targeting blood vessel growth.My brain metastases have been stable for less than 4 weeks.My advanced colorectal cancer is MSI-high or has DNA repair issues.I have been diagnosed with reversible brain swelling.I have type 1 or type 2 diabetes.I do not have severe nerve pain or damage.I am currently being treated for nerve damage in my hands or feet.I am using birth control as required by local laws.I have an active hole or abnormal connection in my digestive tract.I am fully active or can carry out light work.I have had heart problems, like a heart attack or heart failure.My blood tests show normal white blood cells, platelets, and hemoglobin levels.I do not have any severe, uncontrolled infections like HIV or Hepatitis B/C.I have not had major surgery in the last 4 weeks.I am 18 years old or older.I am able to understand and sign the consent form.My high blood pressure is not well-controlled despite taking medication.My liver functions within the normal range required.I have been diagnosed with advanced colon or rectal cancer.I have issues with wounds not healing well or bleeding problems.I can't walk but can sit up and use a wheelchair by myself.
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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