Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with pathologically confirmed locally advanced rectal adenocarcinoma who will be receiving total neoadjuvant therapy regimen with curative intent
Women of childbearing potential and male participants must agree to use two forms of a medically effective means of birth control throughout their participation in the treatment phase of the study and until 12 months following the last study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three weeks (during and 2 weeks after rt)
Awards & highlights
Study Summary
This trial is testing an investigational drug in combination with radiation therapy for patients with newly diagnosed rectal cancer. The goal is to see if the drug is effective and safe.
Who is the study for?
Adults over 18 (19 in Nebraska) with locally advanced rectal cancer who are fit for total neoadjuvant therapy can join. They must have certain blood counts, organ function tests, and imaging done recently. Pregnant or breastfeeding individuals, those with significant heart disease, uncontrolled hypertension, recent serious cardiovascular events, or a history of other cancers needing active treatment are excluded.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of BMX-001 when used with either short-course radiotherapy or long-course chemoradiotherapy in patients with newly diagnosed rectal adenocarcinoma as part of their pre-surgery treatment plan.See study design
What are the potential side effects?
Potential side effects may include typical reactions to radiation therapy such as fatigue and skin irritation. Since BMX-001 is investigational, its specific side effects aren't fully known but could be similar to other chemotherapy drugs like nausea or low blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have advanced rectal cancer and will undergo intensive treatment before surgery to try to cure it.
Select...
I agree to use two effective birth control methods during and up to 12 months after the study.
Select...
My kidney function is good, based on recent tests.
Select...
My rectal cancer is at a stage where it needs intensive treatment before surgery.
Select...
I am at least 18 years old, or 19 if I live in Nebraska.
Select...
I can take care of myself but may not be able to do active work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three weeks (during and 2 weeks after rt)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three weeks (during and 2 weeks after rt)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of BMX-001 as measured by Grade 3 and above associated with gastrointestinal Toxicities
Efficacy of BMX-001 as measured by Grade 3 and above associated with genitourinary Toxicities
Efficacy of BMX-001 as measured by Grade 3 and above associated with hematologic Toxicities
+1 moreSide effects data
From 2022 Phase 1 & 2 trial • 29 Patients • NCT02990468100%
Dysgeusia
100%
Dry Mouth
100%
Injection site reaction
100%
Nausea
100%
Constipation
100%
Dehydration
100%
Fatigue
100%
Oropharyngeal pain
100%
Stomatitis
100%
Vomiting
100%
Radiation skin injury
100%
Salivary duct inflammation
67%
Haemoptysis
67%
Neck pain
67%
Pain
67%
Peripheral sensory neuropathy
67%
Weight decreased
67%
Chills
67%
Cough
67%
Mucosal infection
33%
Hypoacusis
33%
Hyponatraemia
33%
Ear pain
33%
Sepsis
33%
Anal incontinence
33%
Confusional State
33%
Dysphonia
33%
Diarrhoea
33%
Dizziness
33%
Early satiety
33%
Lip infection
33%
Lymphoedema
33%
Pain in extremity
33%
Skin mass
33%
Toothache
33%
Urinary tract infection
33%
Skin infection
33%
Dyspepsia
33%
Acute kidney injury
33%
Conduction Disorder
33%
Malaise
33%
Sinus tachycardia
33%
Tinnitus
33%
Dermatitis acneiform
33%
Localised oedema
33%
Hypothyroidism
33%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Group I
Phase 1: Group II
Phase 2: Group III
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Arm CExperimental Treatment1 Intervention
Long Course Chemo-Radiation Therapy (LCCRT) + BMX-001
Group II: Arm AExperimental Treatment1 Intervention
Short Chemo-Radiation Therapy (SCRT) + BMX-001
Group III: Arm DActive Control1 Intervention
Long Course Chemo-Radiation Therapy (LCCRT)
Group IV: Arm BActive Control1 Intervention
Short Chemo-Radiation Therapy (SCRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMX-001
2017
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,277 Total Patients Enrolled
Chi Lin, MD, PhDLead Sponsor
2 Previous Clinical Trials
68 Total Patients Enrolled
University of NebraskaLead Sponsor
535 Previous Clinical Trials
1,143,788 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not needed IV antibiotics for an infection in the last 7 days.I have had rectal cancer before.I have risk factors for a specific heart rhythm problem (like heart failure or low potassium).I have advanced rectal cancer and will undergo intensive treatment before surgery to try to cure it.I have had radiation therapy in the pelvic area for another type of cancer.I agree to use two effective birth control methods during and up to 12 months after the study.I haven't had major blood vessel problems or surgery for them in the last 6 months.My blood counts meet the required levels for hemoglobin, ANC, and platelets.My kidney function is good, based on recent tests.I have had issues with dizziness or fainting when standing up in the past year.I have a brain condition like seizures, but it's under control with medication.I have no active cancer treatments, except for certain skin, cervical, bladder cancers, or low-grade prostate cancer.My heart's electrical cycle is longer than normal.My rectal cancer is at a stage where it needs intensive treatment before surgery.I am not on blood thinners like warfarin, or if I am, my doctor adjusts my dose based on frequent blood tests.I haven't had a serious heart or stroke issue in the last 6 months.I am at least 18 years old, or 19 if I live in Nebraska.I am allergic or react badly to medications in FOLFOX or CAPOX treatments.I can take care of myself but may not be able to do active work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C
- Group 2: Arm D
- Group 3: Arm A
- Group 4: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the potential risks of taking BMX-001?
"While there is some clinical data supporting BMX-001's safety, it has not been proved effective yet and thus received a score of 2."
Answered by AI
Are we looking for more participants in this experiment?
"The listed clinical trial is not accepting patients at this time. Although, if you are interested in participating in a similar study, there are 356 other trials that may be a better fit."
Answered by AI
Share this study with friends
Copy Link
Messenger