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NCT04861987 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
A Phase 1 study of Advanced Cancer and Refractory Cancer, sponsored by Processa Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 6
- Study locations
NCT04861987: Completed Phase 1 study of Advanced Cancer and Refractory Cancer, sponsored by Processa Pharmaceuticals.
NCT04861987 is a Phase 1 study of Advanced Cancer and Refractory Cancer that has completed, run by Processa Pharmaceuticals. The registered enrollment target is 23 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04861987, a Phase 1 study of Advanced Cancer and Refractory Cancer, has completed, sponsored by Processa Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 6
- Study locations
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.
Primary Outcome
Frequency, duration, and severity of DLTs and adverse events (AEs)
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 |
What the finished NCT04861987 record still lists
NCT04861987 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (91% lower).
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.
NCT04861987 lists 6 locations in 6 states (Nebraska, New Jersey, New Mexico).
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.
What interventions are being tested in trial NCT04861987?
The interventions under investigation include: PCS6422 and capecitabine (DRUG).
Who is sponsoring clinical trial NCT04861987?
This trial is sponsored by Processa Pharmaceuticals, which has 9 total clinical trials registered on ClinicalTrials.gov.
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
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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 NCT04861987's enrollment target sits among peer trials
23 110th of 122 higher than 13 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer 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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