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

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

INTRODUCTION

  • Org Study ID: TYRA-001-BC-2021
  • Secondary ID: N/A
  • NTC ID: NCT05052372
  • Sponsor: xCures

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.

DETAILED DESCRIPTION

The purpose of this study is to collect biomarker data from subjects receiving standard of care erdafitinib to further investigate the relationship between treatment with erdafitinib and clinical response, progression, and/or genetic alterations in cell free tumor DNA (cfDNA) from blood and urine samples.

In this study, next generation sequencing of cfDNA isolated from blood and urine will be performed by Resolution Bioscience. Blood-based cfDNA amplification and analysis is done by a CLIA-approved assay and the results of which will thus be available to physicians and patients. Urine-based cfDNA analysis from Resolution Bioscience is not yet approved and results will only be communicated if an actionable finding is identified that is not present on the blood-based test. Samples will be collected at the patients homes by a qualified phlebotomist.

xCures may provide the treating physician and the subject the biomarker results from blood-based cfDNA tests. Because the testing of urine DNA is experimental and done solely for research, those results will not be shared unless there is an important finding known to be relevant to the subject's medical care at the time of the study. The genetic tests are not approved for bladder cancer, so the information generated from biomarker research studies is preliminary in nature. Therefore, the significance and scientific validity of the results are undetermined. xCures and/or Tyra may additionally share data with the treating physician and researchers for the purposes of publication.

Patients co-enroll in an observational research study (XCELSIOR, NCT03793088) and consent to provide xCures right of access to their full medical records under HIPAA.

Patient clinical data is structured and centralized by xCures in a 21 CFR Part 11-compliant REDCap Cloud database in Case Report Forms (CRFs). The CRFs are a set of electronic forms for each patient that provides a record of clinical data generated according to the protocol. Data is abstracted directly from medical records generated in the standard practice of medicine.

xCures will request medical records directly from treating institutions and from other providers (commercial next generation sequencing providers, for example) and will work with treating physicians to ensure the completeness and accuracy of CRF content based on electronic medical records.

  • Overall Status
    Recruiting
  • Start Date
    September 2021
  • Phase
  • Study Type
    Observational

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Relationship between treatment with erdafitinib and clinical response

Primary Outcome 1 - Timeframe: Time to progression will vary for each patient. We expect most patients to progress on erdafitinib within 2 to 15 months from baseline

CONDITION

  • 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

ELIGIBILITY

Inclusion Criteria:
Subjects with a diagnosis of locally advanced or metastatic bladder caner

- 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).
Exclusion Criteria:
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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Daniel J. George, MD

Role: Principal Investigator

Affiliation: Duke Health

Overall Contact

Name: Daniel J. George, MD

Phone: (707) 641-4475

Email: expandedaccess@xcures.com

LOCATION

Facility Status Contact
Facility: xCures Virtual Site
Raleigh, North Carolina 27612
United States
Status: Recruiting Contact: Contact
xCures Clinical Operations
707-641-4475
tyrastudy@xcures.com