Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

NCT06328491 | Completed

• 2 other identifiers: OZUHN-01422-5325
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cancer; Steroid Cell Tumor, Malignant

Outcome Measures

Primary Outcomes (2)

• Tumor response

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

  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.

  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.

Study Arms (1)

Erdafitinib in metastatic steroid-cell tumor of the ovary

EXPERIMENTAL

Erdafitinib, 8 mg, orally, once daily. Dose increase to 9 mg once daily may be considered based on serum phosphate levels and tolerability.

Drug: Erdafitinib

Interventions

Erdafitinib DRUG

Protein Kinase Inhibitor

Also known as: Balversa

Erdafitinib in metastatic steroid-cell tumor of the ovary

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

erdafitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Amit Oza, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: March 25, 2024
• Study Start: May 30, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: March 25, 2024

Record last verified: 2024-03

Locations

CA (1)