Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations

This study is looking into a new medication called JNJ-42756493 for people who have advanced solid tumours. This means cancers that have spread to other parts of the body and are not bladder cancers. The study is specifically for those whose cancer has a particular genetic change known as an FGFR alteration. Both adults (aged 18 and over) and children can take part. The main goal of the study is to find out how many people respond to the treatment. This means how many patients see their tumour shrink or disappear completely after taking the medicine. Understanding these responses will help doctors learn more about how effective this new treatment might be for people with these specific types of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Janssen Cilag International

Enrolment target

Start

15 Mar 2024

Advanced solid tumors (other than Urothelial tumors)and FGFR gene alterations.

What is this study about?

This study is like a detailed investigation into a new medicine called JNJ-42756493. It's designed for people who have advanced solid cancers, which means cancers that have grown or spread. This study focuses on people whose cancer cells have a specific change in their genes called an FGFR alteration. This genetic change can sometimes make cancer grow, so the new medicine is designed to target this specific alteration.

Researchers want to see if this medicine can help shrink these tumours or even make them disappear. They will carefully monitor how patients respond to the treatment. This is a "Phase 2" study, which means the researchers are trying to understand if the medicine works well and is safe enough for further testing in larger groups of people.

By taking part, you would be helping doctors learn more about this specific type of cancer and whether this new treatment could be a good option for future patients. It's an important step in finding better ways to treat cancer that has this particular genetic change.

Key takeaways

Tests a new drug for advanced solid tumours.
For cancers with a specific genetic change (FGFR alteration).
Open to adults and children.
Aims to see if the drug shrinks or makes tumours disappear.
Not for bladder cancer.
You can withdraw at any time.

Who may be eligible?

To be able to join this study, you need to be at least 18 years old or older. The study is open to both men and women.

Your cancer must be an advanced solid tumour, meaning it has spread or is growing, and it cannot be a bladder cancer. Most importantly, your cancer cells must have a specific change in their genes called an FGFR alteration. This can usually be found by testing your tumour tissue.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I 18 years old or older? (Or am I a child whose doctor thinks this study is suitable?)
Do I have an advanced solid tumour?
Is my cancer *not* a bladder cancer?
Has my doctor confirmed that my cancer has an 'FGFR gene alteration'?
Am I able to travel to study appointments if needed?

Answer every question to see your result.

What does participation involve?

The detailed information about what taking part involves hasn't been fully provided in the summary. However, in most clinical trials like this, you can expect:

* **Regular Hospital Visits:** You would likely need to attend appointments at a hospital or clinic. These visits would be for check-ups, to receive your medication (if it's not taken at home), and to have tests done. * **Assessments:** These tests might include blood tests, scans (like CT or MRI scans) to see how your tumour is responding, and possibly other examinations. These are done regularly to monitor your health and the effect of the treatment. * **Taking Medication:** You would be given the study medication, JNJ-42756493, as directed by the study team. This would involve specific instructions on how and when to take it. * **Follow-up:** Even after you stop taking the study medication, there might be follow-up appointments or phone calls to see how you are doing over time. * **Total Duration:** The total time you spend in the study can vary greatly depending on how you respond to the treatment and the study's design. The medical team would explain this fully before you decide to join.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to a new treatment that isn't widely available yet, which might help your specific condition. You would also receive careful medical monitoring throughout the study. However, like all medicines, the study drug JNJ-42756493 may have side effects, and it might not work for everyone. The study team will explain all known side effects and potential risks to you in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Spain

Common questions

What is an 'advanced solid tumour'?

This means a cancer that started in an organ and has either grown larger or spread to other parts of your body. It is not skin cancer that has not spread, blood cancer, or bladder cancer in this study.

What is an 'FGFR gene alteration'?

This is a specific change in the genetic information within your cancer cells. These changes can sometimes make cancer grow, and doctors can test for them.

What does 'Phase 2 study' mean?

A Phase 2 study is a stage of clinical research where doctors give a new drug to a larger group of patients. They want to see if the drug is effective and to further check for side effects.

What is the new medicine called?

The medicine being tested in this study is called JNJ-42756493.

Will I definitely get the study medicine?

It's highly likely you would if you meet the full eligibility criteria, as this study is therapeutic exploratory, meaning everyone typically receives the experimental treatment.