Your session is about to expire
← Back to Search
Fluoropyrimidine
NUC-3373 + Chemotherapy for Colorectal Cancer
Phase 2
Waitlist Available
Research Sponsored by NuCana plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from baseline to 30 days after last dose of study drug
Awards & highlights
Study Summary
This trial is comparing 3 treatments for colorectal cancer to measure their efficacy and safety. 171 patients will be randomized to each regimen.
Who is the study for?
This trial is for adults with advanced colorectal cancer that can't be removed by surgery. They must have had previous chemotherapy, know their UGT1A1 status (or agree to testing), and not have certain genetic mutations or serious health conditions. Women of childbearing age need a negative pregnancy test and must use effective contraception.Check my eligibility
What is being tested?
The study compares NUC-3373 combined with leucovorin, irinotecan, and bevacizumab against the standard treatment using 5-FU instead of NUC-3373. Patients are randomly assigned to one of three groups receiving different schedules of these drugs to see which works best.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, fatigue, digestive issues like nausea or diarrhea, increased risk of infections due to lowered white blood cells, bleeding complications from low platelets, anemia from low red blood cell counts, liver function changes, and potential skin sensitivity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed from baseline to 30 days after last dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from baseline to 30 days after last dose of study drug
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients achieving progress-free survival (PFS)
Secondary outcome measures
Number of patients achieving a reduction in tumour volume
Number of patients reporting treatment-emergent adverse events (TEAEs)
Number of patients surviving
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: NUFIRI-bev on a Q2W NUC-3373 scheduleExperimental Treatment4 Interventions
Arm B: Study treatment will be administered in 28-day cycles as follows:
Bevacizumab 5 mg/kg on Days 1 and 15:
90 minutes for the first dose
60 minutes for the second dose (if first dose is tolerated)
30 minutes for subsequent doses (if second dose is tolerated)
LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
NUC-3373 1500 mg/m2 over 120 minutes on Days 1 and 15.
Group II: NUFIRI-bev on a Q1W NUC-3373 scheduleExperimental Treatment4 Interventions
Arm A: Study treatment will be administered in 28-day cycles as follows:
Bevacizumab 5 mg/kg on Days 1 and 15:
90 minutes for the first dose
60 minutes for the second dose (if first dose is tolerated)
30 minutes for subsequent doses (if second dose is tolerated)
LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
NUC-3373 1500 mg/m2 over 120 minutes on Days 1, 8, 15, and 22.
Group III: FOLFIRI-bev on a Q2W scheduleActive Control4 Interventions
Arm C: Study treatment will be administered in 28-day cycles as follows:
Bevacizumab 5 mg/kg on Days 1 and 15:
90 minutes for the first dose
60 minutes for the second dose (if first dose is tolerated)
30 minutes for subsequent doses (if second dose is tolerated)
LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
5-FU 400 mg/m2 bolus on Days 1 and 15.
5-FU 2400 mg/m2 infusion over 46 hours on Days 1 and 15.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Leucovorin
2005
Completed Phase 4
~5730
Bevacizumab
2013
Completed Phase 4
~5280
Find a Location
Who is running the clinical trial?
NuCana plcLead Sponsor
5 Previous Clinical Trials
1,118 Total Patients Enrolled
Elisabeth Oelmann, MD, PhDStudy DirectorNuCana plc
1 Previous Clinical Trials
91 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is not controlled by medication.I am currently taking St John's Wort.I have been treated with irinotecan before.My cancer has the BRAF V600E mutation.I need regular blood transfusions.I am fully active or can carry out light work.I am allergic or cannot take certain chemotherapy drugs like 5-FU.I have or had cancer spread to my brain or spinal cord.My cancer is MSI-H or has dMMR.I am allergic to ingredients in the NUC-3373 medication.I have not had a serious blood clot in the past 6 months.My liver is working well.I have not coughed up blood in the last 6 months.I have an unhealed wound, stomach ulcer, or broken bone.I am currently taking brivudine, sorivudine, or similar drugs.I am taking medication that affects my heart's electrical cycle.My colorectal cancer cannot be surgically removed and has spread.I know my DPD activity status or agree to be tested.I have a known bleeding disorder.I have never had major surgery on my small intestine or a history of serious gut problems.I am 18 years old or older.I have had fluid in my abdomen that needed draining recently.My kidney function is normal.I do not have any serious illnesses that would stop me from joining the study.I know my cancer's RAS and BRAF gene status.I am taking medication that strongly affects liver enzyme activity.I know my UGT1A1 status or agree to be tested.I have been advised to protect my skin and eyes from UV light.I am a woman who can have children and have a recent negative pregnancy test.I do not have severe kidney problems related to protein loss.I've had a specific chemotherapy for my cancer that has spread, or it came back within 6 months after finishing treatment.I haven't had surgery or wound healing issues in the last 28 days.I haven't had serious gut or abdominal infections or holes in the past 6 months.I do not have an active infection, HIV, or active hepatitis B or C.My bone marrow is working well.I have had chemotherapy with targeted therapy before.
Research Study Groups:
This trial has the following groups:- Group 1: NUFIRI-bev on a Q1W NUC-3373 schedule
- Group 2: NUFIRI-bev on a Q2W NUC-3373 schedule
- Group 3: FOLFIRI-bev on a Q2W schedule
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.
Has the FDA cleared NUFIRI-bev for a one week administration of NUC-3373?
"While there is a certain level of evidence suggesting the security of NUFIRI-bev on a Q1W NUC-3373 regimen, no data exists that conclusively shows its efficacy. Therefore, it has been assigned a safety score of 2."
Answered by AI
What is the sample size of participants in this clinical trial?
"Affirmative. Clinicaltrials.gov states that this experimental procedure, which was first made public on January 1st 2023, is actively searching for participants. A total of 171 people need to be recruited from two separate medical establishments"
Answered by AI
Are there still opportunities to enroll in this experiment?
"Confirmed, the clinical trial is actively enrolling patients. According to information found on clinicaltrials.gov, this study was published on January 1st 2023 and updated for a final time in September of that year. Specifically, 171 people are being sought after from two distinct medical facilities."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger