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AU409 for Liver Cancer
Phase 1
Recruiting
Led By Anthony B El-Khoueiry, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up 3 years
Awards & highlights
Study Summary
This trial tests the safety and effectiveness of a new intervention, AU409, for primary liver cancer and metastatic liver tumors. It may help stop cancer from growing and spreading.
Who is the study for?
This trial is for adults with advanced primary liver cancers or solid tumors that have spread to the liver. Participants must have tried all standard treatments, be in good physical condition (ECOG 0-1), and not be pregnant or breastfeeding. They should also meet specific blood count and organ function criteria, agree to use contraception, and not have certain medical conditions like active infections or recent heart issues.Check my eligibility
What is being tested?
The trial tests AU409's safety, side effects, and optimal dosage on patients with advanced liver cancer or those whose solid tumors have metastasized to the liver. It aims to find out if AU409 can halt cancer growth and spread by collecting biospecimens and using imaging techniques like CT scans and MRIs.See study design
What are the potential side effects?
While specific side effects of AU409 are being studied in this trial, common ones may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could also occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Maximum Tolerated Dose
Recommended phase II dose
Secondary outcome measures
Objective radiologic response
Pharmacokinetics evaluation - Peak plasma concentration (Cmax)
Pharmacokinetics evaluation - Peak time (Tmax)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (AU409)Experimental Treatment4 Interventions
Patients receive AU409 PO on study. Patients also undergo CT or MRI and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Computed Tomography
2017
Completed Phase 2
~2720
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,252 Total Patients Enrolled
5 Trials studying Cholangiocarcinoma
151 Patients Enrolled for Cholangiocarcinoma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,818 Total Patients Enrolled
101 Trials studying Cholangiocarcinoma
9,734 Patients Enrolled for Cholangiocarcinoma
Auransa, Inc.UNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My liver cancer is advanced with a moderate to severe impact on my health.I haven't had cancer treatment in the last 28 days.I am taking medication that strongly affects liver enzymes.I have had heart problems in the last 6 months.I have had surgery on my digestive system or have a condition that affects how I absorb nutrients.I finished any cancer treatments at least 4 weeks ago.I have recovered from side effects of my previous cancer treatments.I have active hepatitis B or another infection needing treatment.My advanced cancer is not responding to standard treatments or there are none available.I am currently on warfarin for blood thinning.My liver is working within normal ranges.I have brain metastases that are either untreated or causing symptoms.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is primarily in the liver or has spread mainly to the liver.I agree to a liver biopsy and blood tests for drug level analysis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (AU409)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Treatment (AU409) been endorsed by the FDA?
"Given the limited data surrounding its safety and efficacy, Treatment (AU409) attained a score of 1 on our risk assessment scale."
Answered by AI
Does this research endeavor have openings to include new participants?
"According to the clinicaltrials.gov listing, this experiment is no longer recruiting patients and has not been updated since March 16th 2023. However, there are 5606 other trials that require participants at present."
Answered by AI
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