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NCT04109924 · ClinicalTrials.gov registry record · Phase 2
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04109924: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT04109924 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 42 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109924, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with bevacizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving TAS-102, irinotecan, and bevacizumab may work better in treating patients with colorectal cancer compared to traditional chemotherapy and bevacizumab.
Primary Outcome
Will be assessed via the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 guidelines. The PFS will be summarized using standard Kaplan-Meier methods, where estimates of the median PFS and 6/12-month PFS rates will be obtained with 90% confidence intervals.
Interventions
- DRUG Irinotecan
- BIOLOGICAL Bevacizumab
- DRUG Trifluridine and Tipiracil Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-12-27 |
| Est. Completion | 2024-09-05 |
| Phase | Phase 2 |
What the finished NCT04109924 record still lists
NCT04109924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 3 interventions - of which Irinotecan is the first listed.
NCT04109924 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04109924 about?
NCT04109924 is a clinical study titled "TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study". This phase II trial studies how well TAS-102, irinotecan, and bevacizumab work in treating patients with pre-treated colorectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Drugs used in chemotherapy, such as TAS-102, work in differe...
What is the current status of trial NCT04109924?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-12-27. Estimated completion is 2024-09-05.
What interventions are being tested in trial NCT04109924?
The interventions under investigation include: Irinotecan (DRUG), Bevacizumab (BIOLOGICAL), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04109924?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04109924's enrollment target sits among peer trials
42 1339th of 2000 higher than 649 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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