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Eniluracil + Capecitabine for Gastric Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Group 1: PCS6422 + Capecitabine
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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