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Study of erdafitinib treatment for adults and adolescents with advanced solid tumors having FGFR gene changes

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What is this study about?

This study focuses on patients with advanced solid tumors who have specific genetic changes called FGFR gene alterations. The study will test a medication called erdafitinib (also known as JNJ-42756493), which is given as a film-coated tablet that patients take by mouth.

The purpose of this research is to evaluate how well erdafitinib works in treating advanced solid tumors in both adult and pediatric patients (children and teenagers 6 years and older). The study includes patients whose tumors have specific genetic changes in the FGFR genes, which are alterations that can affect how tumors grow and spread.

During the study, participants will receive erdafitinib tablets daily for treatment periods of 21 days. The maximum daily dose is 9 milligrams. Doctors will monitor how the tumors respond to the treatment using specialized imaging techniques to measure any changes in tumor size. The study will track whether tumors shrink completely, partially, or show no response to the treatment.

1 Initial assessment

Your doctor will confirm if you have an advanced solid tumor with specific FGFR gene changes

Basic health checks will be performed, including blood tests to verify your bone marrow, liver, and kidney function

Your general physical condition will be evaluated using a standardized scale

2 Treatment preparation

Your current symptoms must be stable or mild before starting the treatment

Your phosphate levels will be checked within 14 days before starting treatment

3 Medication administration

You will receive erdafitinib in the form of film-coated tablets

The medication needs to be taken by mouth

Your doctor will provide specific instructions about the dosage and timing

4 Regular monitoring

Your tumor response will be regularly assessed using imaging scans

Blood tests will be performed to monitor your body’s response to treatment

Your doctor will check for any side effects during treatment

5 Treatment continuation

Treatment will continue as long as your disease does not worsen

Regular evaluations will determine if the treatment is working

The study is planned to continue until October 2026

Who Can Join the Study?

  • Must be at least 6 years of age
  • Must have an advanced solid tumor (cancer that has spread) with specific genetic changes called FGFR mutations or fusions
  • Must have cancer that can be measured using standard imaging tests
  • Must have received at least one previous cancer treatment for advanced disease, unless you are a child or teenager with a newly diagnosed tumor that has no standard treatment options
  • Must not have any remaining side effects from previous cancer treatments, except for hair loss, nerve problems, or certain laboratory test results
  • Must have documented cancer progression (worsening of the disease) before starting the study screening process. This does not apply to children who have not received previous treatment
  • For adults (18 years and older): Must be able to perform daily activities with minimal assistance (ECOG performance status of 0 or 1)
  • For children and teenagers (6 to 17 years): Must have a Karnofsky Score of 70 or higher, which means they can care for themselves but may not be able to carry on normal activities
  • Must have adequate bone marrow, liver, and kidney function as shown by specific blood test results
  • Must be willing and able to provide informed consent. For children and teenagers, parents or legal representatives must provide consent, and the young participant must also agree to participate

Who Cannot Join the Study?

  • History of urothelial tumors (cancers that start in the lining of the urinary system)
  • Lack of confirmed FGFR gene alterations (specific genetic changes in the FGFR genes)
  • Previous treatment with FGFR inhibitors (medications that target FGFR gene alterations)
  • Presence of untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions or uncontrolled high blood pressure
  • Significant liver or kidney dysfunction
  • Active infections requiring systemic treatment (medications that affect the whole body)
  • Other ongoing cancer treatments that might interfere with the study medication
  • Pregnancy or breastfeeding
  • Unable to swallow oral medications
  • History of other cancers within the past 2 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Major surgery within 4 weeks before starting the study treatment

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Asklepios Kliniken Hamburg GmbH Hamburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
04.12.2019
Spain Spain
Not recruiting
04.12.2019

Trial locations

Investigated drugs:

Erdafitinib is a targeted therapy medication used to treat advanced solid tumors. It specifically works by targeting abnormalities in FGFR genes (Fibroblast Growth Factor Receptor). This medication is designed to help patients whose tumors have specific genetic changes called FGFR mutations or fusions. It can be used in both adult and pediatric patients, including adolescents, who have these specific genetic markers in their tumors.

Investigated diseases:

Advanced Solid Tumors – A condition where abnormal cells form solid masses or tumors that have spread beyond their original location in the body. These tumors can develop in various organs and tissues, including bones, muscles, or organs. The tumors grow and multiply in an uncontrolled manner, potentially affecting surrounding tissues. Advanced solid tumors are characterized by their progression beyond the initial site where they first appeared. They may involve multiple areas of the body and can vary in size and growth rate.

FGFR Gene Alterations – A genetic condition where changes occur in the Fibroblast Growth Factor Receptor genes, which are responsible for cell growth and division. These alterations can affect how cells develop and multiply in the body. The changes in FGFR genes can be present from birth or develop over time. FGFR gene alterations can affect various parts of the body since these genes play important roles in tissue development and maintenance.

Trial ID:
2023-510301-18-00
Protocol code:
42756493CAN2002
Trial Phase:
Therapeutic exploratory (Phase II)

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