NCT07675057AvailableNot Applicable
Expanded Access for Vepugratinib in Participants With Fibroblast Growth Factor Receptor 3 (FGFR3) Altered Solid Tumors
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Available
- Sponsor
- Eli Lilly and Company
Study Overview
Brief Summary
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Study Design
- Study Type
- Expanded Access
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have metastatic urothelial carcinoma (UC) or other solid tumor with a qualifying fibroblast growth factor receptor 3 (FGFR3) genetic alteration.
- •Have exhausted other approved treatments, including erdafitinib for UC.
- •Are not eligible for an ongoing vepugratinib clinical trial
Exclusion Criteria
- •Currently enrolled in an ongoing clinical study of vepugratinib
- •Have a known severe (greater than or equal to (≥) Grade 3) hypersensitivity to any component or excipient of vepugratinib.
- •Current evidence of corneal keratopathy or retinal disorder confirmed by ocular examination. Exception: Individuals with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk.
- •Significant cardiovascular disease:
- •Are pregnant, breastfeeding, or intent to become pregnant during the study or within 6 months of the last dose of study intervention.
Investigators
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