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A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment

NCT03428958 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2025-04-23

Study results available
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Summary

This is a three-part study of NUC-3373 administered by intravenous (IV) infusion across two administration schedules, either as monotherapy or as part of various combinations with agents commonly used to treat CRC (leucovorin, oxaliplatin, irinotecan, bevacizumab, cetuximab and panitumumab). The primary objective is to identify a recommended dose and schedule for NUC-3373 when combined with these agents.

Conditions

  • Colorectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Colorectal Tumors
  • Neoplasms, Colorectal

Interventions

DRUG

NUC-3373 + leucovorin

NUC-3373 + leucovorin

DRUG

NUC-3373

NUC-3373

DRUG

NUFOX

NUC-3373 + oxaliplatin

DRUG

NUFOX + VEGF pathway inhibitor

NUC-3373 + oxaliplatin + bevacizumab

DRUG

NUFOX + EGFR inhibitor

NUC-3373 + oxaliplatin + cetuximab/panitumumab

DRUG

NUFIRI

NUC-3373 + irinotecan

DRUG

NUFIRI + VEGF pathway inhibitor

NUC-3373 + irinotecan + bevacizumab

DRUG

NUFIRI + EGFR inhibitor

NUC-3373 + irinotecan + cetuximab/panitumumab

DRUG

NUC-3373 + bevacizumab

NUC-3373 + bevacizumab

Sponsors & Collaborators

  • NuCana plc

    lead OTHER

Principal Investigators

  • Elisabeth Oelmann, MD PhD · NuCana plc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-05
Primary Completion
2024-03-19
Completion
2024-03-21
FDA Drug
Yes

Countries

  • United States
  • France
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428958 on ClinicalTrials.gov