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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 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.

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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.

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

FieldValue
Enrollment Target 23 participants
Start Date 2021-06-18
Est. Completion 2024-09-09
Phase Phase 1

Sponsor

Processa Pharmaceuticals

9 total trials

What the Registry Record Tells You About NCT04861987

The ClinicalTrials.gov registry entry for NCT04861987 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Processa Pharmaceuticals, which has 9 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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