NCT03428958

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

A Phase Ib/II Open Label Study to Assess the Safety and Pharmacokinetics of NUC-3373, a Nucleotide Analogue, Given in Combination With Standard Agents Used in Colorectal Cancer Treatment

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: NuCana plc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-10-05
• Primary completion: 2024-03-19
• Completion: 2024-03-21
• First posted: 2018-02-12
• Last updated: 2025-04-23
• Results posted: 2025-04-23

Locations

10 sites across 3 countries: United States, France, United Kingdom

Regulatory

• FDA-regulated drug study