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NCT04163900 · ClinicalTrials.gov registry record · Phase 3
Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer
A Phase 3 study, sponsored by NuCana.
- Terminated
- Registry status
- Phase 3
- Development phase
- 773
- Enrollment target
NCT04163900: Clinical Trial Phase 3 study, sponsored by NuCana.
NCT04163900 is a Phase 3 study that was terminated before completion, run by NuCana. The registered enrollment target is 773 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04163900, a Phase 3 study, was terminated before completion, sponsored by NuCana.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 773 participants
- Enrollment target
Study Summary
NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: * The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care * The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care
Primary Outcome
Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were als
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine
- DRUG NUC-1031
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 773 participants |
| Start Date | 2019-12-24 |
| Est. Completion | 2022-04-05 |
| Phase | Phase 3 |
Why NCT04163900 stopped before completion
NCT04163900 is an interventional study that assigns participants to a tested intervention. The registered 773 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Cisplatin is the first listed.
NCT04163900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04163900 about?
NCT04163900 is a clinical study titled "Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer". NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: * The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin stan...
What is the current status of trial NCT04163900?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 773 participants. The study started on 2019-12-24. Estimated completion is 2022-04-05.
What interventions are being tested in trial NCT04163900?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine (DRUG), NUC-1031 (DRUG).
Who is sponsoring clinical trial NCT04163900?
This trial is sponsored by NuCana, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04163900's enrollment target sits among peer trials
773 440th of 2000 higher than 1,561 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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