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HC-5404-FU Dose Determination for Solid Cancers
Study Summary
This trial is testing a new drug, HC-5404-FU, to see what the maximum tolerated dose is and to evaluate its safety and tolerability. The trial will enroll 36 subjects with specific types of cancer at 3-5 US sites. The starting dose is 25 mg twice daily, escalating to 50, 100, and 200 mg as safety allows. The trial will then expand to assess the most appropriate dose and tumor type(s) selected in Phase 1a as the most appropriate for further clinical development.
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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- If it's safe and you agree, you are willing to have a tissue sample taken for testing.I am 18 years old or older.You have Type I diabetes and need insulin, or you have Type II diabetes that is not well controlled with an A1c level above 8%.I have a specific type of advanced cancer and have had 2-5 treatments for it.I agree to use birth control during and for 90 days after the study.I have been diagnosed with HIV.I will not donate sperm during and for 3 months after treatment.My organs are functioning well enough for treatment.I have another cancer that has been active or treated in the last 5 years.Your albumin level is 3 grams per deciliter or higher during screening.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 90 days after.I haven't had cancer treatment or major surgery in the last 2 weeks, or I've recovered from their side effects.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I am currently being treated for an infection.I have a tumor that can be measured and was confirmed by a scan within the last 28 days.My side effects from previous treatments are mild, except for possible stable numbness or hair loss.I have serious heart problems, including unstable chest pain or a recent heart attack.I have had lung inflammation or pneumonitis in the last year.My kidney function is good as tested within the last 15 days.I have an active case of tuberculosis.I have not taken strong CYP3A4 drugs in the last 4 weeks.Your blood counts need to be normal within 15 days before starting the study drug.You have a current Hepatitis B or Hepatitis C infection.Your blood clotting ability is normal within 15 days before starting the study drug.I have a chronic condition affecting my pancreas or gastrointestinal system.I have a solid tumor cancer, but it's not a fast-growing type like pancreatic cancer.I will use effective birth control during and for 3 months after treatment.Your heart's electrical activity, called the QT interval, should be less than 450 milliseconds when adjusted for your heart rate.I have tested positive for COVID-19 with a PCR test.I am fully active or restricted in physically strenuous activity but can do light work.My cancer has spread to my brain or the membranes around my brain.Your doctor believes you will live for at least 3 more months.I have taken a pregnancy test within the last 72 hours and it was negative.
- Group 1: Cohort 7 - 900 mg
- Group 2: Cohort 8 - 300 mg
- Group 3: Cohort 1 - 25 mg
- Group 4: Cohort 2 - 50 mg
- Group 5: Cohort 3 - 100 mg
- Group 6: Cohort 4 - 200 mg
- Group 7: Cohort 5 - 400 mg
- Group 8: Cohort 6 - 600 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What is the geographic spread of this experimental protocol?
"This study is recruiting participants in various locations, including Baylor University Medical Center (Dallas), The University of Texas M.D. Anderson Cancer Center (Houston) and HealthPartners Cancer Care Center (Saint Paul). Additionally, there are 4 other clinical trial sites available for enrolment."
How many people are actively participating in this trial?
"Affirmative, according to clinicaltrials.gov this study is in the process of enrolling patients. The trial was initially advertised on June 8th 2021 and recently modified on July 7th 2022; it hopes to recruit 36 people from four distinct sites."
Are there still vacancies available for those looking to participate in this clinical investigation?
"Clinicaltrials.gov indicates that recruitment for this clinical trial is ongoing, having begun on the 8th of June 2021 and most recently updated on the 7th of July 2022."
What potential risks does HC-5404-FU pose to individuals?
"As HC-5404-FU is currently a Phase 1 trial, our team at Power rated it with a score of 1. This implies that there is limited data available to support its safety and efficacy."
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What portion of applicants met pre-screening criteria?
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