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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 belowSelect...
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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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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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 am capable of becoming pregnant and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ ~6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~~6 months
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have known allergies to any of the ingredients in the study treatments.I have chronic hepatitis B but my viral load is undetectable with treatment.I can take care of myself and am up and about more than half of my waking hours.My recent tests show my bone marrow, liver, and kidneys are functioning well.I am 18 years old or older.You are expected to live for at least 12 more weeks.My side effects from previous treatments are mild, except for possible nerve pain.I have a known DPD deficiency.I cannot take pills by mouth or have conditions that affect how my body absorbs medication.I do not have serious heart conditions like uncontrolled chest pain or recent heart attacks.I haven't needed treatment for another cancer type, except for certain skin or cervical cancers, in the last 3 years.I am taking medication that is not allowed in the study and cannot stop.I had an electrolyte imbalance but it's now corrected.My GI tract cancer is advanced and hasn't responded to current treatments.My HIV is under control with undetectable viral load due to treatment.I have not had major surgery or significant injury in the last 4 weeks.I haven't had IV or oral 5 FU cancer treatment in the last 4 weeks.I have or someone in my family has a history of long QT syndrome.I have a history of serious heart rhythm problems.My cancer can be measured by standard health guidelines.My cancer has spread to my brain.I have treated my hepatitis C and currently have no detectable virus.My hemoglobin level is at least 8.5 g/dL without needing transfusions.My liver enzymes are within acceptable limits.I agree to use effective birth control during and for 60 days after my treatment.I am capable of becoming pregnant and have a negative pregnancy test.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: PCS6422 + Capecitabine
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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