← Back to Search

Other

Irinotecan, Sonidegib, and Sorafenib for Liver Cancer

Phase 1

Recruiting

Led By Ali Zarrinpar, MD, PhD

Research Sponsored by University of Florida

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 32 days

Awards & highlights

Study Summary

This trial aims to test a new combination of three drugs for treating liver cancer. The study will determine safe doses of the drugs and evaluate their effectiveness in improving patient outcomes compared to the current standard treatment.

Who is the study for?

Adults over 18 with advanced-stage liver cancer (HCC) confirmed by biopsy, who can't have or haven't improved with surgery or local treatments. They should be relatively active (ECOG ≤2), have a life expectancy of at least 12 weeks, and not be dealing with other serious cancers. Their liver must still work fairly well (Child-Pugh A or B7), and they need to have at least one measurable tumor that hasn’t been treated.Check my eligibility

What is being tested?

The trial is testing a new combination of three drugs: sorafenib, sonidegib, and irinotecan. It aims to find safe doses for these drugs when used together in liver cancer patients. The study will use AI to personalize drug dosing for each patient to maximize benefits while reducing side effects. Success will be measured by looking at changes in ctDNA levels in the blood and how well patients tolerate treatment.See study design

What are the potential side effects?

Possible side effects include damage to organs due to toxicity from the medications, which could affect how well they function. Patients might also experience general discomforts like nausea or fatigue as their bodies react to the drug combination.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 32 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~32 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 32 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximally tolerated dose

Secondary outcome measures

Change in the biomarker AFP

Change in the biomarker AFP-L3

Change in the biomarker DGC

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Irinotecan, Sonidegib, and SorafenibExperimental Treatment3 Interventions

Subjects will be assigned to a dose of each drug following a 3 + 3 design

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sonidegib

2014

Completed Phase 2

~100

Irinotecan

2017

Completed Phase 4

~2680

Sorafenib

2014

Completed Phase 3

~1670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sun Pharmaceutical Industries LtdUNKNOWN

1 Previous Clinical Trials

20 Total Patients Enrolled

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,634 Total Patients Enrolled

1 Trials studying Liver Cancer

41 Patients Enrolled for Liver Cancer

Ali Zarrinpar, MD, PhDPrincipal InvestigatorUniversity of Florida

2 Previous Clinical Trials

67 Total Patients Enrolled

Frequently Asked Questions

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

Is the clinical trial enrolling participants who are younger than 80 years old?

"Individuals aged 18 or older up to the age of 99 are eligible for participation as per the entry requirements of this research study."

Answered by AI

What is the upper limit for the number of participants involved in this research endeavor?

"Indeed, as per the details provided on clinicaltrials.gov, this study is actively in search of suitable candidates. The trial's initial posting was on April 1st, 2024 and its latest update occurred on March 28th, 2024. A total of 12 participants are sought from a singular designated site."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Indeed, the information available on clinicaltrials.gov shows that this medical research study is actively seeking participants. The trial was initially listed on April 1st, 2024, and its most recent update occurred on March 28th, 2024. This investigation aims to recruit a total of 12 patients from one designated site."

Answered by AI

Have Irinotecan, Sonidegib, and Sorafenib received official approval from the Food and Drug Administration (FDA)?

"In this Phase 1 trial, the safety of Irinotecan, Sonidegib, and Sorafenib is rated as 1 by our team at Power due to the scarcity of data supporting their safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma

2024. "AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05669339.

All > Hcc > Hepatocellular Carcinoma