Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib

NCT05052372 | Terminated FDA Drug

• 1 other identifier: TYRA-001-BC-2021
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder cancers are associated with genetic mutations that are present in the patient's bladder or urothelium, the lining of the lower urinary tract. Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer. This study will collect biomarker data from subjects receiving erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations.

Conditions

Bladder Cancer; Urothelial Carcinoma; Transitional Cell Carcinoma; Platinum-Resistant Urothelial Carcinoma; Bladder Urothelial Carcinoma; FGFR Mutation; FGFR2 Gene Mutation; FGFR3 Gene Mutation; FGFR2 Amplification; Locally Advanced Urothelial Carcinoma; Metastatic Urothelial Carcinoma; Refractory Bladder Carcinoma; Refractory Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Relationship between treatment with erdafitinib and clinical response

  Specimen collection will be performed at the following timepoints to assess clinical response while being treated with erdafitinib: 1. Baseline (prior to or within 7 days of starting erdafitinib) 2. Suspicion of progression (optional) 3. Post-progression

  Time to progression will vary for each patient. We expect most patients to progress on erdafitinib within 2 to 15 months from baseline

Interventions

Balversa DRUG

BALVERSA® is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients in the United States with a diagnosis of locally advanced or metastatic bladder cancer (TCC/UC) may be screened for this study. In order to enroll on the study, subjects must have documented proof of an FGFR alteration according to a CLIA-based test with planned treatment with erdafitinib, or currently undergoing treatment with erdafitinib.

You may qualify if:

• Subjects with a diagnosis of locally advanced or metastatic bladder cancer
• Documented proof of an FGFR alteration according to a CLIA-based test
• Subjects who are receiving or will receive erdafitinib as their standard medical therapy as a monotherapy or in combination
• Age greater than or equal to 18 years.
• Subject is a resident of or seeking care in the United States
• Able and willing to provide informed consent to this biomarker study
• Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088).

You may not qualify if:

• Subjects younger than 18 years of age
• Subjects unwilling or unable to provide informed consent
• Subjects that are not receiving treatment in the United States or US Territories

Sponsors & Collaborators

• xCures: lead

Study Sites (1)

xCures Virtual Site

Raleigh, North Carolina, 27612, United States

Location

Related Publications (1)

• Facchinetti F, Hollebecque A, Bahleda R, Loriot Y, Olaussen KA, Massard C, Friboulet L. Facts and New Hopes on Selective FGFR Inhibitors in Solid Tumors. Clin Cancer Res. 2020 Feb 15;26(4):764-774. doi: 10.1158/1078-0432.CCR-19-2035. Epub 2019 Oct 4.

  PMID: 31585937 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Liquid biopsies (blood and urine) will be collected at two or three timepoints per each patient approximately within a 2 to 15 month timeframe. 3 x 10 mL ctDNA whole blood collection 1 x 5 mL Random Urine collection DNA from blood plasma and urine will be isolated and tumor DNA will be purified. Samples will be stored securely and may be kept for up to 5 years after the last subject completes the study

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell

Interventions

erdafitinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Daniel J. George, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: September 22, 2021
• Study Start: November 21, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: December 22, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)