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NCT04042714 · ClinicalTrials.gov registry record · Phase 2
TAS-102 in Extrapulmonary Neuroendocrine Carcinoma
A Phase 2 study, sponsored by Baylor Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT04042714: Clinical Trial Phase 2 study, sponsored by Baylor Research Institute.
NCT04042714 is a Phase 2 study that was terminated before completion, run by Baylor Research Institute. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04042714, a Phase 2 study, was terminated before completion, sponsored by Baylor Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and efficacy of drug, TAS-102 (trifluridine/tipiracil), in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer. TAS-102 demonstrated improved survival and tolerability in patients with colorectal cancer and is currently approved by the FDA and marketed under the brand name Lonsurf for the treatment of patients with metastatic colorectal cancer (mCRC). Recently, a study evaluating TAS-102 showed a case of complete remission of high-grade NEC. Given the safety profile of TAS-102 and the remarkable single agent activity in a disease with otherwise dismal outcomes, we hope that TAS-102 may show tolerability and efficacy in neuro-endocrine cancer and propose further exploration in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer.
Primary Outcome
To assess clinical activity \[ORR = Partial response (PR)+Complete response (CR) \] of TAS-102 in patients with metastatic, extra pulmonary high grade NEC
Interventions
- DRUG All patients- TAS-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2019-08-15 |
| Est. Completion | 2025-10-15 |
| Phase | Phase 2 |
Why NCT04042714 stopped before completion
NCT04042714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which All patients- TAS-102 is the first listed.
NCT04042714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04042714 about?
NCT04042714 is a clinical study titled "TAS-102 in Extrapulmonary Neuroendocrine Carcinoma". The purpose of this study is to test the safety and efficacy of drug, TAS-102 (trifluridine/tipiracil), in patients with extrapulmonary (outside the lung) high-grade neuroendocrine cancer. TAS-102 demonstrated improved survival and tolerability in patients with colorectal cancer and is currently app...
What is the current status of trial NCT04042714?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2019-08-15. Estimated completion is 2025-10-15.
What interventions are being tested in trial NCT04042714?
The interventions under investigation include: All patients- TAS-102 (DRUG).
Who is sponsoring clinical trial NCT04042714?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04042714's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 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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