Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

NCT06328491CompletedNAINTERVENTIONAL

Summary

This is a single participant study of erdafitinib for the treatment of a patient with metastatic steroid-cell tumor of the ovary.

Key Facts

Lead Sponsor

University Health Network, Toronto

Enrollment

1

Start Date

2022-05-30

Completion Date

2022-08-22

Study Type

INTERVENTIONAL

Official Title

Erdafitinib in Metastatic Steroid-cell Tumor of the Ovary, NOS

Interventions

Erdafitinib

Conditions

Ovarian CancerSteroid Cell TumorMalignant

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria \& Exclusion Criteria:

This is a single patient study and the protocol was specifically designed for this single patient. This patient case was discussed in the hospital expert molecular tumor board rounds consisting of representatives from specialist genomic profiling and gynecologic medical oncology departments. The discussion surrounded the best next therapeutic option in this extremely rare cancer subtype without clear standard of care guidelines. The recommendation from this discussion was to perform radiation therapy to her bone lesion and access target treatment against FGFR4 amplification, such as Erdafitinib that is a pan FGFR kinase inhibitor and binds to and inhibits FGFR1, FGFR2, FGFR3, and FGFR4 enzyme activity.

Outcome Measures

Primary Outcomes

Tumor response

Response will be measured radiographically with restaging CT thorax, abdomen and pelvis every 9-12 weeks while on treatment.

Time frame: Until disease progression or until the investigator deems that it is in the patient's best interest to stop study treatment whichever came first, assessed up to 3 months.

Overall health status

Clinical endpoints will include overall performance status including Eastern Cooperative Oncology Group (ECOG) score and patient-reported symptoms. There will be no formal data analysis.

Time frame: Until disease progression or until the investigator deems that it is in the patient's best interest to stop study treatment whichever came first, assessed up to 3 months.

Locations

Princess Margaret Cancer Centre, Toronto, Canada

Erdafitinib in Metastatic Steroid-cell Ovarian Cancer