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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
No Placebo-Only Group
Summary
This trial is testing two combinations of cancer drugs on patients with advanced colorectal cancer that can't be removed by surgery. One combination includes a new drug called NUC-3373, and the other uses a traditional drug. The goal is to see which combination works better at killing cancer cells and stopping their growth.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of patients achieving progress-free survival (PFS)
Secondary study objectives
Number of patients achieving a reduction in tumour volume
Number of patients reporting treatment-emergent adverse events (TEAEs)
Number of patients surviving
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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:
1. 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)
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 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:
1. 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)
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1, 8, 15, and 22.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 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:
1. 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)
2. LV 400 mg/m2 (or equivalent levo-LV) over 120 minutes on Days 1 and 15.
3. Irinotecan 180 mg/m2 over 90 minutes (concurrently with the LV infusion) on Days 1 and 15.
4. 5-FU 400 mg/m2 bolus on Days 1 and 15.
5. 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 3
~2590
Leucovorin
2005
Completed Phase 4
~6010
Bevacizumab
2013
Completed Phase 4
~5540
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for colorectal cancer include fluoropyrimidines like 5-FU and its novel counterpart NUC-3373, which inhibit thymidylate synthase, disrupting DNA synthesis and cell division. Leucovorin enhances the binding of 5-FU to its target enzyme, increasing its efficacy.
Irinotecan inhibits topoisomerase I, preventing DNA replication and transcription, leading to cell death. Bevacizumab is an anti-angiogenic agent that inhibits VEGF, reducing blood supply to tumors and hindering their growth.
These mechanisms are crucial as they target different aspects of cancer cell survival and proliferation, offering a multi-faceted approach to treatment and potentially improving patient outcomes.
Find a Location
Who is running the clinical trial?
NuCana plcLead Sponsor
5 Previous Clinical Trials
1,159 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.