Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Crouzon Syndrome

Jackson-Weiss Syndrome

Pfeiffer Syndrome

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

Balversa

Daniel J. George, MD

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.

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.

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

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

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

xCures

Infections

Symptoms and General Pathology

Communicable Diseases

Urinary Tract Infections

Disease Attributes

Anti-Infective Agents

All Drugs and Chemicals

Antineoplastic Agents

Anti-Dyskinesia Agents

Micronutrients

Hematinics

Vitamins

Anti-Bacterial Agents

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Levofloxacin

Ofloxacin

Antibiotics, Antitubercular

Nitrofurantoin

Trimethoprim, Sulfamethoxazole Drug Combination

Trimethoprim

Sulfamethoxazole

Ertapenem

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

Diary

Trimethoprim-Sulfamethoxazole

Khurshid A. Guru

Khurshid A Guru

This trial investigates whether a one-month course of preventative (prophylactic) antibiotics helps to reduce urinary tract infections after robot-assisted surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). Urinary tract infections are a common occurrence after robot-assisted radical cystectomy. Antibiotics such as trimethoprim-sulfamethoxazole or nitrofurantoin may prevent or control infections in patients with urinary tract infection and may help improve their response to radical cystectomy. Information gained from this study may help researchers to predict patient complications and identify better ways to manage these complications.

PRIMARY OBJECTIVE:

I. To determine if the utilization of a prophylactic antibiotic during the postoperative period will decrease the rate of urinary tract infection (UTI) post robot-assisted radical cystectomy.

SECONDARY OBJECTIVE:

I. To identify pre- and post-operative factors that may be associated with the development of a 90-day UTI following radical cystectomy.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ANTIBIOTIC): Patients receive ertapenem orally (PO), levofloxacin PO, or clindamycin PO induction therapy per standard of care. At the time of full diet, patients receive trimethoprim-sulfamethoxazole PO daily or nitrofurantoin PO daily on days 1-30. Patients complete a drug diary for each day they receive the antibiotic.

GROUP II (CONTROL): Patients receive ertapenem PO, levofloxacin PO, or clindamycin PO induction therapy per standard of care.

After surgery, patients are followed up to 120 days.

Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy

Does Prophylactic Antibiotic Decrease the Rate of Urinary Tract Infection After Robot Assisted Radical Cystectomy

Will be treated as dichotomous data and will be summarized by group using frequencies and relative frequencies.

stratified logistic regression models (stratified by antibiotic use)

Will be evaluated in patients who received prophylactic antibiotics.

To identify which antibiotic is better suited as a prophylactic, comparisons will be made using two-sided Mann-Whitney U and Fisher's exact tests for continuous and categorical variables, respectively.

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib	NCT05052372	Bladder Cancer Urothelial Carc... Transitional Ce... Platinum-Resist... Bladder Urothel... FGFR Mutation FGFR2 Gene Muta... FGFR3 Gene Muta... FGFR2 Amplifica... Locally Advance... Metastatic Urot... Refractory Blad... Refractory Blad...	Balversa	18 Years -	xCures
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib	NCT05052372	Bladder Cancer Urothelial Carc... Transitional Ce... Platinum-Resist... Bladder Urothel... FGFR Mutation FGFR2 Gene Muta... FGFR3 Gene Muta... FGFR2 Amplifica... Locally Advance... Metastatic Urot... Refractory Blad... Refractory Blad...	Balversa	18 Years -	xCures
Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy	NCT04502095	Bladder Carcino... Refractory Blad... Urinary Tract I...	Clindamycin Diary Ertapenem Levofloxacin Nitrofurantoin Trimethoprim-Su...	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for refractory bladder carcinoma