Trials / Completed
CompletedNCT06328491
Erdafitinib in Metastatic Steroid-cell Ovarian Cancer
Erdafitinib in Metastatic Steroid-cell Tumor of the Ovary, NOS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single participant study of erdafitinib for the treatment of a patient with metastatic steroid-cell tumor of the ovary.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Erdafitinib | Protein Kinase Inhibitor |
Timeline
- Start date
- 2022-05-30
- Primary completion
- 2022-08-22
- Completion
- 2022-08-22
- First posted
- 2024-03-25
- Last updated
- 2024-03-25
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06328491. Inclusion in this directory is not an endorsement.