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NCT03287947 · ClinicalTrials.gov registry record · Phase 2
LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT03287947: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT03287947 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03287947, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of this trial is to evaluate the disease control rate of nintedanib in subjects with metastatic appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on previous studies, the anticancer activity of nintedanib in lung and ovarian cancer trials, along with the similarities between appendiceal and colorectal cancer and potentially ovarian cancer, warrant additional investigation for the optimal treatment of metastatic appendiceal carcinomas.
Primary Outcome
The disease control rate is the proportion of those subjects with complete response, partial response, or stable disease, as defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per RECIST 1.1 criteria for target lesions assessed by radiologic evaluation of CT and tumor measurements: Complete Response (CR), Disappearance of all target and non-target lesions, any pathological lymph nodes reduced in short axis to \<10 mm; Partial Response (PR), \>=30% decrease in the sum
Interventions
- DRUG nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-11-10 |
| Est. Completion | 2019-10-27 |
| Phase | Phase 2 |
Why NCT03287947 stopped before completion
NCT03287947 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which nintedanib is the first listed.
NCT03287947 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03287947 about?
NCT03287947 is a clinical study titled "LCI-GI-APX-NIN-001: Nintedanib in Metastatic Appendiceal Carcinoma". The purpose of this trial is to evaluate the disease control rate of nintedanib in subjects with metastatic appendiceal cancer for whom initial fluoropyrimidine-based chemotherapy has failed. Based on previous studies, the anticancer activity of nintedanib in lung and ovarian cancer trials, along wi...
What is the current status of trial NCT03287947?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2017-11-10. Estimated completion is 2019-10-27.
What interventions are being tested in trial NCT03287947?
The interventions under investigation include: nintedanib (DRUG).
Who is sponsoring clinical trial NCT03287947?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03287947's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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