Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2022-08-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ovarian Cancer Steroid Cell Tumor, Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Erdafitinib

Intervention Type DRUG

Protein Kinase Inhibitor

Interventions

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Erdafitinib

Protein Kinase Inhibitor

Intervention Type DRUG

Other Intervention Names

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Balversa

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No