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Topoisomerase I inhibitors

NUC-3373 for Colorectal Cancer

Phase 1 & 2
Recruiting
Research Sponsored by NuCana plc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All patients
Life expectancy of ≥12 weeks
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 testing NUC-3373, a new cancer drug, given by IV infusion. The study will test different combinations of NUC-3373 with other cancer drugs, to find the best dose and schedule for treatment.

Eligible Conditions
  • Colorectal Cancer
  • Colorectal Tumor

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Everyone is included in this criteria.
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You are expected to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed from baseline to 30 days after last dose of study drug
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed from baseline to 30 days after last dose of study drug for reporting.

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 reporting treatment-emergent adverse events (TEAEs)
Number of patients with treatment-emergent clinically significant changes in laboratory parameters, ECG changes, or changes in physical examinations
Secondary outcome measures
Tolerability of NUC-3373 in each combination cohort measured by dose intensity in Cycle 1

Trial Design

15Treatment groups
Experimental Treatment
Group I: NUFOX + cetuximabExperimental Treatment1 Intervention
Arm 3f: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, oxaliplatin will be administered every other week and cetuximab will be administered weekly.
Group II: NUFOX + bevacizumab weeklyExperimental Treatment1 Intervention
Arm 3a: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV will be administered weekly, oxaliplatin and bevacizumab will be administered every other week.
Group III: NUFOX + bevacizumab every other weekExperimental Treatment1 Intervention
Arm 3b: NUC-3373, LV and oxaliplatin at dose levels used in Arm 2a will be combined with bevacizumab. NUC-3373+LV+oxaliplatin+bevacizumab will be administered every other week.
Group IV: NUFIRI + cetuximabExperimental Treatment1 Intervention
Arm 3g: NUC-3373, LV and irinotecan at dose levels used in Arm 2b may be administered in subsequent cetuximab cohorts. NUC-3373+LV may be administered weekly or every other week, irinotecan will be administered every other week and cetuximab will be administered weekly.
Group V: NUFIRI + bevacizumab weeklyExperimental Treatment1 Intervention
Arm 3c: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV will be administered weekly, irinotecan and bevacizumab will be administered every other week.
Group VI: NUFIRI + bevacizumab every other weekExperimental Treatment1 Intervention
Arm 3d: NUC-3373, LV and irinotecan at dose levels used in Arm 2b will be combined with bevacizumab. NUC-3373+LV+irinotecan+bevacizumab will be administered every other week.
Group VII: NUC-3373 every other weekExperimental Treatment1 Intervention
Arm 1b: LV 400 mg/m2 administered IV over 2 hours prior to NUC-3373 infusion followed by a 2-week washout period. Then, NUC-3373 administered IV every 2 weeks without LV in 28-day cycles.
Group VIII: NUC-3373 + oxaliplatin weeklyExperimental Treatment1 Intervention
Arm 2a: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
Group IX: NUC-3373 + oxaliplatin (NUFOX) expansionExperimental Treatment1 Intervention
Arm 2c: At the completion of Arm 2a, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with oxaliplatin (85 mg/m2) administered on Days 1 and 15.
Group X: NUC-3373 + leucovorin (LV); combination chemotherapy ineligibleExperimental Treatment1 Intervention
Arm 1d: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV on Days 1, 8, 15 and 22 of 28-day cycles.
Group XI: NUC-3373 + leucovorin (LV) weeklyExperimental Treatment1 Intervention
Arm 1c: LV 400 mg/m2 administered IV over 2 hours followed by NUC-3373 administered IV weekly on Days 1, 8, 15 and 22 of 28-day cycles.
Group XII: NUC-3373 + leucovorin (LV) every other weekExperimental Treatment1 Intervention
Arm 1a: NUC-3373 administered IV followed by a 2-week washout period. The next dose of NUC-3373 administered in combination with LV at 400 mg/m2. All subsequent doses of NUC-3373 administered in combination with LV every 2 weeks in 28-day cycles.
Group XIII: NUC-3373 + irinotecan weeklyExperimental Treatment1 Intervention
Arm 2b: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
Group XIV: NUC-3373 + irinotecan (NUFIRI) expansionExperimental Treatment1 Intervention
Arm 2d: At the completion of Arm 2b, the recommended dose of NUC-3373 (+LV 400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with irinotecan (180 mg/m2) on Days 1 and 15.
Group XV: NUC-3373 + LV + bevacizumab; maintenance patientsExperimental Treatment1 Intervention
Arm 3e: NUC-3373+LV (400 mg/m2) administered weekly on Days 1, 8, 15 and 22 of 28-day cycles in combination with bevacizumab (administered every other week).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NUC-3373
2016
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

NuCana plcLead Sponsor
5 Previous Clinical Trials
1,182 Total Patients Enrolled
Elisabeth Oelmann, MD PhDStudy DirectorNuCana plc
2 Previous Clinical Trials
147 Total Patients Enrolled

Media Library

Irinotecan (Topoisomerase I inhibitors) Clinical Trial Eligibility Overview. Trial Name: NCT03428958 — Phase 1 & 2
Colorectal Cancer Research Study Groups: NUC-3373 + leucovorin (LV) every other week, NUC-3373 every other week, NUC-3373 + leucovorin (LV) weekly, NUC-3373 + leucovorin (LV); combination chemotherapy ineligible, NUC-3373 + oxaliplatin weekly, NUC-3373 + irinotecan weekly, NUC-3373 + oxaliplatin (NUFOX) expansion, NUC-3373 + irinotecan (NUFIRI) expansion, NUFOX + bevacizumab weekly, NUFOX + bevacizumab every other week, NUFIRI + bevacizumab weekly, NUFIRI + bevacizumab every other week, NUC-3373 + LV + bevacizumab; maintenance patients, NUFOX + cetuximab, NUFIRI + cetuximab
Colorectal Cancer Clinical Trial 2023: Irinotecan Highlights & Side Effects. Trial Name: NCT03428958 — Phase 1 & 2
Irinotecan (Topoisomerase I inhibitors) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03428958 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still able to sign up for this experiment?

"The trial is currently ongoing, as seen from the study's listing on clinicaltrials.gov. This particular research project was first made public on October 16th, 2018 with the most recent update happening January 12th, 2022."

Answered by AI

How many individuals are helping to contribute to this research project?

"Yes, the information on clinicaltrials.gov point out that this study is actively recruiting participants. The clinical trial was initially posted on 10/16/2018 and was most recently updated on 1/12/2022. The trial is recruiting for 225 participants across 3 sites."

Answered by AI

What are some of the benefits associated with taking NUC-3373?

"NUC-3373 is often used to treat colorectal carcinoma, but it can also help patients with conditions like locally advanced nonsquamous non-small cell lung cancer and sarcoma who have developed an intolerance to irinotecan."

Answered by AI

Is NUC-3373 a new or previously explored drug?

"At present, 988 studies are ongoing concerning NUC-3373. 266 of those trials are currently in Phase 3. A large number of these studies originate from Guangzhou, Guangdong; however, 40666 research locations worldwide are conducting investigations into this potential treatment."

Answered by AI
~35 spots leftby Mar 2025