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Study on the Effectiveness and Safety of Erdafitinib, Midazolam, and Metformin in Patients with Advanced Urothelial Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as urothelial cancer, which affects the bladder and other parts of the urinary system. The study is testing a treatment called JNJ-42756493, also known as erdafitinib, which is a medication taken by mouth in the form of a film-coated tablet. The purpose of the study is to evaluate how effective and safe this medication is for patients with urothelial cancer that cannot be removed by surgery or has spread to other parts of the body. The study also looks at how erdafitinib affects the body when taken with other medications, such as midazolam and metformin.

Participants in the study will receive erdafitinib to see how their cancer responds to the treatment. The study will monitor the participants' health and any changes in their cancer over time. The trial will also assess how erdafitinib interacts with midazolam, which is often used to help with anxiety or sedation, and metformin, a common medication for diabetes. These interactions are important to understand how erdafitinib might affect the way these other drugs work in the body.

The study is designed to gather information on the best dose of erdafitinib and to observe any side effects or benefits experienced by the participants. By doing so, researchers hope to find a treatment option that can help manage urothelial cancer more effectively. The trial is open-label, meaning both the researchers and participants know which treatment is being administered, and it involves multiple centers to ensure a comprehensive evaluation of the medication's effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of metastatic or surgically unremovable urothelial cancer with specific FGFR genetic changes.
A measurable disease must be present according to specific criteria, and a performance status score is evaluated to ensure it is within the acceptable range.
Step 2
Baseline evaluation
A comprehensive evaluation is performed to establish baseline health status. This includes tests to ensure adequate bone marrow, liver, and kidney function.
For women of childbearing potential, a pregnancy test is conducted to confirm a negative result.
Step 3
Treatment initiation
The treatment phase begins with the administration of erdafitinib in the form of a film-coated tablet taken orally. The specific dosage and frequency are determined based on the study protocol.
The objective is to assess the response of the cancer to the treatment regimen.
Step 4
Medication interaction study
During the trial, the effects of erdafitinib on the body's processing of other medications, such as midazolam and metformin, are evaluated.
Midazolam is administered as an oral solution, and metformin is given as a film-coated tablet. The study examines how these medications interact when taken with erdafitinib.
Step 5
Ongoing monitoring
Regular monitoring is conducted to track the cancer's response to the treatment and to observe any side effects or changes in health status.
This includes periodic imaging and laboratory tests to assess the effectiveness and safety of the treatment.
Step 6
Completion of treatment
The treatment continues until there is evidence of disease progression or until the study's end date, which is estimated to be December 31, 2024.
At the end of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

8 criteria

Must have a confirmed diagnosis of **metastatic** or **surgically unresectable urothelial cancer**. This means the cancer has spread to other parts of the body or cannot be removed by surgery. It's okay if the cancer has some different cell types or has become more aggressive.
Must have **measurable disease** according to specific guidelines. This means the cancer can be measured using medical imaging tests.
Must have an **ECOG performance status score** of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities. A score of 0 means fully active, while 2 means unable to work but can take care of themselves.
Must have adequate **bone marrow, liver, and kidney function**. This means these organs are working well enough to handle the treatment.
Women who can become pregnant must have a **negative pregnancy test** before starting the study.
Must have shown **disease progression** after previous chemotherapy for metastatic or surgically unresectable urothelial cancer. This means the cancer has continued to grow or spread despite treatment.
Subjects with specific **FGFR mutations** or **FGFR gene fusions** are eligible. These are specific changes in the genes that may affect how the cancer grows.
The subject or their legal representative must sign a document called **informed consent**. This shows they understand the study and agree to participate.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer than the one being studied.
Patients who do not have the specific genetic changes required for the study.
Patients who have had certain treatments recently that might interfere with the study.
Patients with other serious health conditions that could affect their safety during the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures for any reason.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies to the study medication or its ingredients.
Patients who have had a recent surgery that might affect their participation.
Patients who have a history of certain heart problems.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Hospital Universitario 12 De Octubre
Madrid, Spain
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Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
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Hospital Vall d’Hebron
Barcelona, Spain

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Investigated drugs

Erdafitinib
is a medication being studied for its effectiveness in treating urothelial cancer that cannot be removed by surgery or has spread to other parts of the body. It works by targeting specific genetic changes in the cancer cells, known as FGFR genomic alterations, which can help slow down or stop the growth of the cancer.
Midazolam
is used in this study to understand how erdafitinib affects the body's processing of other medications. Midazolam is a medication that helps with relaxation and sleep, and it is used here to see how erdafitinib influences its breakdown in the body.
Metformin
is another medication used in the study to assess the impact of erdafitinib on the body's handling of drugs. Metformin is commonly used to manage blood sugar levels in people with diabetes, and in this trial, it helps researchers understand how erdafitinib might affect the way the body processes certain substances.

What is already known about the treatment

Erdafitinib – Erdafitinib is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating urothelial cancer, particularly in cases where the cancer is metastatic or cannot be surgically removed. It is a pan-FGFR tyrosine kinase inhibitor, which means it works by blocking the activity of fibroblast growth factor receptors (FGFR) that are involved in the growth and spread of cancer cells. This medication is classified as a targeted cancer therapy, focusing on specific genetic alterations in cancer cells. The ongoing research aims to determine the best dosing regimen and assess its safety and efficacy in patients with FGFR genomic alterations.

Investigated diseases

Urothelial Cancer – Urothelial cancer is a type of cancer that begins in the urothelial cells lining the bladder and other parts of the urinary tract. It is the most common form of bladder cancer and can also occur in the ureters and urethra. The disease often starts in the innermost layer of the bladder wall and can grow into deeper layers over time. As it progresses, it may spread to nearby tissues and organs, and in advanced stages, it can metastasize to distant parts of the body. Symptoms may include blood in the urine, frequent urination, and pain during urination. The progression of the disease can vary, with some cases remaining superficial while others become invasive.