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Anti-metabolites

Eniluracil + Capecitabine for Gastric Cancer

Phase 1
Recruiting
Research Sponsored by Processa Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If patient has chronic hepatitis B infection and is receiving antiviral treatment, has a negative viral load at Screening.
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ~6 months
Awards & highlights

Study Summary

This trial is for patients with advanced stomach or intestinal cancer who have not responded to other treatments or can't tolerate other treatments.

Who is the study for?
This trial is for adults with advanced GI tract tumors that are resistant to standard treatments or who can't tolerate them. They should not have had certain cancer drugs in the last month, must be able to perform daily activities (ECOG 0-2), and have a life expectancy of at least 12 weeks. Participants need proper liver, kidney, and bone marrow function and agree to use contraception.Check my eligibility
What is being tested?
The study tests PCS6422 (Eniluracil) combined with capecitabine in patients with gastrointestinal cancers that are either recurring after treatment or cannot be treated by other therapies. It's an open-label trial where all participants know what treatment they're getting.See study design
What are the potential side effects?
Possible side effects include those common to chemotherapy such as nausea, vomiting, diarrhea, fatigue, hand-foot syndrome (redness/pain/swelling of hands/feet), low blood cell counts increasing infection risk, and potential heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic hepatitis B but my viral load is undetectable with treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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My recent tests show my bone marrow, liver, and kidneys are functioning well.
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I am 18 years old or older.
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My side effects from previous treatments are mild, except for possible nerve pain.
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My GI tract cancer is advanced and hasn't responded to current treatments.
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My HIV is under control with undetectable viral load due to treatment.
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I haven't had IV or oral 5 FU cancer treatment in the last 4 weeks.
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My cancer can be measured by standard health guidelines.
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I have treated my hepatitis C and currently have no detectable virus.
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My hemoglobin level is at least 8.5 g/dL without needing transfusions.
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My liver enzymes are within acceptable limits.
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I agree to use effective birth control during and for 60 days after my treatment.
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I am capable of becoming pregnant and have a negative pregnancy test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and ~6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Plasma Concentration (Cmax) of capecitabine
Number of participants with dose limiting toxicities (DLT) and incidence of adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Maximum Plasma Concentration (Cmax) of PCS6422
Number of participants with Adverse Events of Special Interest (AESI)
QTc effect of PCS6422

Trial Design

1Treatment groups
Experimental Treatment
Group I: PCS6422 + CapecitabineExperimental Treatment1 Intervention
Fixed dose of PCS6422 combined with various doses of Capecitabine administered in 14 day cycles

Find a Location

Who is running the clinical trial?

Processa PharmaceuticalsLead Sponsor
8 Previous Clinical Trials
266 Total Patients Enrolled
Sian Bigora, Pharm. DStudy DirectorProcessa Pharmaceuticals

Media Library

Capecitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04861987 — Phase 1
Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04861987 — Phase 1
Cancer Research Study Groups: PCS6422 + Capecitabine
Capecitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04861987 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are PCS6422 and capecitabine considered to be secure for medical use?

"Based on the limited clinical data, our experts at Power judged PCS6422 and capecitabine to be of a low safety risk relative to other drugs, garnering it a score of 1."

Answered by AI

Are there any other healthcare facilities undertaking this research experiment within the state?

"This trial is presently enrolling from 5 different sites, located in New Brunswick, Santa Fe and Fairfax as well as two additional urban areas. To reduce travel needs for participants, it's beneficial to select the centre closest to you."

Answered by AI

To what extent are participants engaging in this medical research?

"Affirmative. Clinicaltrials.gov documents that this investigation, which was first published on June 18th 2021, is actively recruiting volunteers. Approximately 42 individuals need to be enrolled from 5 different healthcare centres."

Answered by AI

Could you provide any additional details regarding the research conducted on PCS6422 and capecitabine?

"Presently, 334 clinical trials probing PCS6422 and capecitabine are in progress. Of those studies, 126 of them are currently at the Phase 3 stage. Most research centres studying this medication can be found in Woolloongabba, Queensland; yet there exists a total of 12828 locations conducting tests for these treatments."

Answered by AI

What is the underlying objective of this experiment?

"This six-month trial seeks to measure the Maximum Plasma Concentration (Cmax) of capecitabine, as well as evaluate the effect on QTc of PCS6422 and determine the frequency, duration, and severity of Adverse Events of Special Interest (AESIs). Furthermore, it will assess Cmax levels for PCS6422."

Answered by AI

Are any slots still available for participation in this research endeavor?

"As indicated on clinicaltrials.gov, the recruitment period for this medical trial is still ongoing. The initial post was published June 18th 2021 and the most recent edit occurred February 4th 2022."

Answered by AI

What therapeutic applications are PCS6422 and capecitabine commonly utilized for?

"PCS6422 and capecitabine are commonly employed against malignant neoplasms, but have also been used to treat pancreatic endocrine carcinoma, colorectal carcinoma, and refractory ovarian cancer."

Answered by AI
~11 spots leftby Mar 2025