Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06328491
• Other study ID #: OZUHN-014
• Secondary ID: 22-5325
• Status: Completed
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: August 22, 2022

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Erdafitinib was approved by FDA in 2019 for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR alterations. Blocking the FGF/FGFR signaling axis by tyrosine kinase inhibitors was proved to be a successful therapeutic strategy in numerous tumor types. Erdafitinib was the first approved FGFR-TKI for treating metastatic urothelial carcinoma based on remarkable results of the phase II trial (BLC2001), that enrolled 212 patients of whom 101 patients was treated with uptitration dose of 9mg daily. The median follow-up for efficacy was 24 months (IQR 22.7*26.6). The objective response rate was 40% (95% CI) of 101 patients of uptitration group. The common grade 3-4 adverse events were stomatitis and hyponatremia4. A phase III trial (NCT03390504) is being performed to compare the efficacy of Erdafitinib versus Vinflunine or Docetaxel or Pembrolizumab in advanced urothelial cancer. Multiple clinical trials are being conducted on the effectiveness of Erdafitinib in a variety of cancers that harbors FGFR alterations. These indicate the potential to improve control in this rare disease which otherwise is devastating and associated with a very high likelihood of recurrence and poor survival.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 22, 2022
• Est. primary completion date: August 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Erdafitinib
Protein Kinase Inhibitor

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.