Study Comparing Erdafitinib with Other Treatments for Advanced Urothelial Cancer with Specific FGFR Gene Changes
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT03390504
This clinical trial is testing the effectiveness of erdafitinib compared to standard chemotherapy or the drug pembrolizumab in patients with advanced urothelial cancer that has specific FGFR gene changes and has progressed after previous treatments.
Patient Parameters
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Program Overview
The study aims to find out if erdafitinib is more effective than standard treatments like chemotherapy (using drugs such as docetaxel or vinflunine) or pembrolizumab for patients with advanced urothelial cancer that has specific changes in the FGFR gene. Participants will be divided into two groups: one group has had previous treatment with an anti-PD-(L)1 drug, and the other group has not. The study will monitor participants from the start of treatment until the cancer progresses, side effects become too severe, or the participant or doctor decides to stop treatment. Researchers will assess how well the treatment works, its safety, and its impact on patients' quality of life.
Description
This study is testing erdafitinib against standard treatments for advanced urothelial cancer with specific FGFR gene changes. Participants will be randomly assigned to receive either erdafitinib or standard treatment, which could be chemotherapy or pembrolizumab. The study will include a screening phase, a treatment phase, and a follow-up phase. During the treatment phase, participants will continue treatment until their cancer progresses, they experience intolerable side effects, or they choose to stop. After treatment ends, participants will be followed up to monitor their health and any long-term effects of the treatment. The study will also have a long-term extension phase for those who continue to benefit from the treatment. Researchers will evaluate the effectiveness of the treatment, how the body processes the drug, and any side effects. They will also collect information on how the treatment affects patients' quality of life and use of medical resources.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of urothelial cancer, which may include some minor variations in cell type.
- The cancer must be advanced, meaning it has spread or cannot be removed by surgery.
- The cancer must have progressed, requiring a change in treatment.
- For Cohort 1: Must have had previous treatment with an anti-PD-(L)1 drug, with no more than two prior treatments.
- For Cohort 2: Must not have had previous treatment with an anti-PD-(L)1 drug, with only one prior treatment.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
- Must meet specific molecular criteria related to FGFR gene changes.
- Must have a performance status score of 0, 1, or 2, indicating good overall health.
- Must have adequate bone marrow, liver, and kidney function.
Exclusion Criteria
- Have participated in another clinical trial or received an investigational drug within 30 days before starting this study.
- Have other active cancers that required treatment changes in the last 24 months, except for certain skin or prostate cancers.
- Have cancer that has spread to the brain and is causing symptoms.
- Have previously been treated with an FGFR inhibitor.
- Have known allergies or intolerance to erdafitinib or its ingredients.
- Have current eye conditions like central serous retinopathy.
- Have a history of uncontrolled heart disease.
- Have impaired wound healing, such as chronic ulcers or unhealed surgical wounds.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Urological Institute dba Alaska Clinical Research Center | 99503 | Anchorage | Alaska |
| University of Calif Davis Medical Center | 95817 | Sacramento | California |
| St. Helena Hospital - Martin-O'Neil Cancer Center | 94574 | St. Helena | California |
| MedStar Georgetown University Hospital | 20007 | Washington D.C. | District of Columbia |
| University of Miami Sylvester Cancer Center | 33136 | Miami | Florida |
| Mid Florida Hematology Oncology | 32763 | Orange | Florida |
| Piedmont Cancer Institute | 30318-0922 | Atlanta | Georgia |
| Rush University | 60612 | Chicago | Illinois |
| Edward Hines Jr V A Hospital | 60141 | Hines | Illinois |
| Norton Cancer Institute | 40207 | Louisville | Kentucky |
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