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BXQ-350 for Colorectal Cancer (ASIST Trial)
ASIST Trial 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.
ASIST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowASIST Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ASIST Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: BXQ-350
- Group 2: Placebo
- 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.
Frequently Asked Questions
What are the fundamental aims of this clinical experiment?
"According to the trial sponsor, Bexion Pharmaceuticals Inc., this clinical study will have a primary outcome of Recommended Phase 2 Dose and be measuring it over 6 months. Secondary objectives include assessing Post-Oxaliplatin Symptoms with the Patient Symptom Questionnaire (PSQ), determining Disease Control Rate (DCR) through best overall response (BOR) according to RECIST guidelines, and calculating Peak Plasma Concentration (Cmax)."
How many participants have been enrolled in the experiment thus far?
"This clinical trial needs 195 qualified patients, who meet the stated inclusion criteria. They can take part in this experiment at University of Kentucky/Markey Cancer Center in Lexington and Prisma Health, Institute for Translational Oncology Research in Greenville."
Are there any spaces still available in this clinical trial for participants?
"Data hosted on clinicaltrials.gov affirms that this medical trial is searching for patient applicants. It was initially posted November 1st 2022 and has since been revised October 28th 2022."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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