Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

March 20, 2024 updated by: University Health Network, Toronto

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Erdafitinib in metastatic steroid-cell tumor of the ovary
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
Protein Kinase Inhibitor
Other Names:
  • Balversa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
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.
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Amit Oza, M.D., Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Actual)

August 22, 2022

Study Completion (Actual)

August 22, 2022

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

March 20, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OZUHN-014
  • 22-5325 (Other Identifier: University Health Network)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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