Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
NCT04861987 · View on ClinicalTrials.gov ↗
Study Summary
This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.
Conditions Studied
Interventions
- DRUG PCS6422 and capecitabine
Study Locations (6)
Nebraska
- Processa Clinical Site — Omaha
New Jersey
- Processa Clinical Site — New Brunswick
New Mexico
- Processa Clinical Site — Santa Fe
New York
- Processa Clinical Site — New York
Ohio
- Processa Clinical Site — Cleveland
Virginia
- Processa Clinical Site — Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2021-06-18 |
| Est. Completion | 2024-09-09 |
| Phase | Phase 1 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04861987
The ClinicalTrials.gov registry entry for NCT04861987 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Processa Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 1 intervention — of which PCS6422 and capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04861987 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Nebraska, New Jersey, New Mexico. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04861987 about?
NCT04861987 is a clinical study titled "A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors". This study is an open label, multicenter study in patients who have advanced, relapsed refractory GI cancer or are not relapsed/refractory but are intolerant to other therapies who, in the judgment of investigators, are candidates for fluoropyrimidine monotherapy.
What is the current status of trial NCT04861987?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2021-06-18. Estimated completion is 2024-09-09.
What conditions does trial NCT04861987 study?
This clinical trial studies the following conditions: Advanced Cancer, Refractory Cancer, Tumor Gastric. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04861987?
The interventions under investigation include: PCS6422 and capecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04861987?
This trial is sponsored by Processa Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04861987 being conducted?
This trial has 6 study locations across Nebraska, New Jersey, New Mexico, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.