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NCT04074343 · ClinicalTrials.gov registry record · Phase 1
TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma
A Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT04074343: Completed Phase 1 study, sponsored by University of California, Irvine.
NCT04074343 is a Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04074343, a Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.
Primary Outcome
This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of ne
Interventions
- DRUG Irinotecan
- DRUG TAS-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-08-26 |
| Est. Completion | 2022-07-21 |
| Phase | Phase 1 |
What the finished NCT04074343 record still lists
NCT04074343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Irinotecan is the first listed.
NCT04074343 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04074343 about?
NCT04074343 is a clinical study titled "TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma". This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prio...
What is the current status of trial NCT04074343?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-08-26. Estimated completion is 2022-07-21.
What interventions are being tested in trial NCT04074343?
The interventions under investigation include: Irinotecan (DRUG), TAS-102 (DRUG).
Who is sponsoring clinical trial NCT04074343?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04074343's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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