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NCT03428958 · ClinicalTrials.gov registry record · Phase 1
A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment
A Phase 1 study of Colorectal Cancer and Colorectal Neoplasms, sponsored by NuCana.
- Completed
- Registry status
- Phase 1
- Development phase
- 111
- Enrollment target
- 10
- Study locations
NCT03428958: Completed Phase 1 study of Colorectal Cancer and Colorectal Neoplasms, sponsored by NuCana.
NCT03428958 is a Phase 1 study of Colorectal Cancer and Colorectal Neoplasms that has completed, run by NuCana. The registered enrollment target is 111 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (93% lower). The trial reports 10 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03428958, a Phase 1 study of Colorectal Cancer and Colorectal Neoplasms, has completed, sponsored by NuCana.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 111 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Efficacy (per RECIST v 1.1): defined as the best percentage change from baseline in tumour size (mm)
Conditions Studied
Interventions
- DRUG NUC-3373 + leucovorin
- DRUG NUC-3373
- DRUG NUFOX
- DRUG NUFOX + VEGF pathway inhibitor
- DRUG NUFOX + EGFR inhibitor
Study Locations (10)
Other
- Hopital Franco-Britannique - Levallois-Perret
- The Beatson West of Scotland Cancer Centre - Glasgow
- University College London Hospitals NHS Foundation Trust - London
- University of Oxford - Oxford
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Washington
- Seattle Cancer Center - Seattle
- Compass Oncology - Vancouver
North Carolina
- Duke University Medical Center - Durham
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2018-10-05 |
| Est. Completion | 2024-03-21 |
| Phase | Phase 1 |
What the finished NCT03428958 record still lists
NCT03428958 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (93% lower).
The record links to 5 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions - of which NUC-3373 + leucovorin is the first listed.
NCT03428958 lists 10 locations in 5 states (Other, Massachusetts, Washington).
Frequently Asked Questions
What is clinical trial NCT03428958 about?
NCT03428958 is a clinical study titled "A Safety, Pharmacokinetic and Efficacy Study of NUC-3373 in Combination With Standard Agents Used in Colorectal Cancer Treatment". 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 pri...
What is the current status of trial NCT03428958?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 111 participants. The study started on 2018-10-05. Estimated completion is 2024-03-21.
What conditions does trial NCT03428958 study?
This clinical trial studies the following conditions: Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Neoplasms, Colorectal, Colorectal Tumors.
What interventions are being tested in trial NCT03428958?
The interventions under investigation include: NUC-3373 + leucovorin (DRUG), NUC-3373 (DRUG), NUFOX (DRUG), NUFOX + VEGF pathway inhibitor (DRUG), NUFOX + EGFR inhibitor (DRUG).
Who is sponsoring clinical trial NCT03428958?
This trial is sponsored by NuCana, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03428958 being conducted?
This trial has 10 study locations across Massachusetts, North Carolina, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03428958's enrollment target sits among peer trials
111 210th of 381 higher than 172 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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