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NCT03368963 · ClinicalTrials.gov registry record · Phase 1
TAS102 in Combination With NAL-IRI in Advanced GI Cancers
A Phase 1 study of Gastric Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, sponsored by Emory University.
- Active
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 3
- Study locations
NCT03368963: Active Phase 1 study of Gastric Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, sponsored by Emory University.
NCT03368963 is a Phase 1 study of Gastric Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 64 participants, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (74% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03368963, a Phase 1 study of Gastric Adenocarcinoma and Metastatic Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by surgery. Drugs used in the chemotherapy, such as trifluridine/tipiracil hydrochloride combination agent TAS-102 and nanoliposomal irinotecan, 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.
Primary Outcome
Assessed using Common Terminology Criteria for Adverse Events version 4.0.
Conditions Studied
Interventions
- DRUG Trifluridine and Tipiracil Hydrochloride
- DRUG Nanoliposomal Irinotecan
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2018-01-30 |
| Est. Completion | 2025-11-28 |
| Phase | Phase 1 |
What the registry record for NCT03368963 still lists
NCT03368963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (74% lower).
The record links to 10 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Trifluridine and Tipiracil Hydrochloride is the first listed.
NCT03368963 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03368963 about?
NCT03368963 is a clinical study titled "TAS102 in Combination With NAL-IRI in Advanced GI Cancers". This phase I/II trial studies the best dose and how well trifluridine/tipiracil hydrochloride combination agent TAS-102 (TAS-102) and nanoliposomal irinotecan work in treating patients with gastrointestinal cancers that have spread to other places in the body (metastatic) or cannot be removed by sur...
What is the current status of trial NCT03368963?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2018-01-30. Estimated completion is 2025-11-28.
What conditions does trial NCT03368963 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Colorectal Adenocarcinoma, Stage IV Pancreatic Cancer, Stage IV Gastric Cancer.
What interventions are being tested in trial NCT03368963?
The interventions under investigation include: Trifluridine and Tipiracil Hydrochloride (DRUG), Nanoliposomal Irinotecan (DRUG).
Who is sponsoring clinical trial NCT03368963?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03368963 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03368963's enrollment target sits among peer trials
64 23rd of 47 higher than 24 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Adenocarcinoma 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.
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