Study of Bemcentinib and Pacritinib for Advanced Lung Adenocarcinoma
Sponsor: The University of Texas Health Science Center at San Antonio
ClinicalTrials ID:NCT06516887
This clinical trial is testing a new combination of two drugs, bemcentinib and pacritinib, to see if they are safe and effective for treating advanced lung adenocarcinoma that has not responded to previous treatments.
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Program Overview
The study aims to find out if combining two drugs, bemcentinib and pacritinib, is safe and can help treat advanced lung adenocarcinoma. Researchers will test different doses to find the safest and most effective amount. The study will also look at how the drugs work in the body and their effects on the cancer.
Description
The main goal of this study is to determine the safety and best dose of two drugs, bemcentinib and pacritinib, when used together to treat advanced lung adenocarcinoma. This type of cancer has not responded to other treatments. The study will start by giving patients increasing doses of the drug combination to find the maximum dose that can be tolerated without severe side effects. Researchers will also study how the drugs are processed in the body and their impact on the cancer. The study uses a special method to find the best dose, which helps reduce the risk of giving too much of the drugs. Patients will receive the drug combination at different dose levels until the best dose is found.
Eligibility Criteria
Inclusion Criteria
- Have advanced lung adenocarcinoma that has not responded to at least one previous treatment.
- Be 18 years or older.
- Have a life expectancy of at least 3 months.
- Have good liver and kidney function based on specific blood tests.
- Have adequate blood cell counts.
- Be able to swallow and tolerate oral medications.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
- Agree to provide informed consent and follow study procedures.
- Be willing to consider biopsies if safe and feasible.
- Have no significant abnormalities in urine tests.
- Have acceptable blood clotting times.
- Be non-fertile or agree to use effective contraception during the study and for 90 days after the last dose.
Exclusion Criteria
- Have certain heart conditions, such as recent heart attack or uncontrolled heart disease.
- Have a history of seizures requiring medication.
- Have active brain metastases requiring treatment.
- Have had major surgery within 2 weeks before starting the study.
- Have active infections requiring treatment.
- Be pregnant or breastfeeding.
- Have received certain treatments within 28 days before the study.
- Have uncontrolled diarrhea or recent significant bleeding.
- Be taking certain medications that affect the study drugs.
- Have a history of severe allergic reactions to similar drugs.
- Have conditions that affect drug absorption.
- Be unable to stop taking certain stomach medications before the study.
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