Study on Lirafugratinib for Treating Non-Cholangiocarcinoma Solid Tumors with FGFR2 Gene Changes
Sponsor: Elevar Therapeutics
ClinicalTrials ID:NCT07359820
This clinical trial is testing the effectiveness and safety of the drug lirafugratinib in adults with advanced solid tumors, excluding cholangiocarcinoma, that have specific changes in the FGFR2 gene. Participants will take the medication as directed and attend regular clinic visits for monitoring.
Patient Parameters
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Program Overview
The purpose of this study is to determine if lirafugratinib is a safe and effective treatment for adults with advanced solid tumors (excluding cholangiocarcinoma) that have specific changes in the FGFR2 gene. Participants will take the medication regularly, visit the clinic for checkups and tests, and keep a diary to record each dose they take.
Eligibility Criteria
Inclusion Criteria
- Have an advanced solid tumor that cannot be removed by surgery, excluding cholangiocarcinoma.
- Have a confirmed change in the FGFR2 gene, as shown by local testing of blood or tumor samples.
- Have measurable disease according to standard criteria.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have received at least one previous treatment for cancer, such as chemotherapy, immunotherapy, or radiation, more than 30 days ago.
- Have not been treated with an FGFR inhibitor before.
Exclusion Criteria
- Have an uncontrolled medical condition.
- Do not have adequate organ function as defined in the study protocol.
- Have an active infection, such as HIV, hepatitis B, or hepatitis C, unless well-controlled as defined in the study protocol.
- Have a heart condition with a QT interval longer than 480 milliseconds or a history of related heart issues.
- Have significant, uncontrolled heart disease.
- Have cancer that has spread to the brain or a primary brain tumor causing worsening neurological symptoms.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 85054 | Phoenix | Arizona |
| Mayo Clinic | 32224 | Jacksonville | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
| University of Chicago Medical Center | 60637 | Chicago | Illinois |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Mayo Clinic | 55905 | Rochester | Minnesota |
| The University of Texas M.D. Anderson Cancer Center | 77030 | Houston | Texas |
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