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A Study to Identify Participants With Advanced Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955913
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
The purpose of this study is to identify participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations through molecular testing of their archival tumor tissue.

Condition or disease Intervention/treatment
Urothelial Cancer Receptors, Fibroblast Growth Factor Other: Archival Tumor Tissue Sample

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarker Study to Identify Subjects With Advanced Urothelial Cancer and Fibroblast Growth Factor Receptor Gene Aberrations
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : June 10, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Participants with Urothelial Cancer,selected FGFR aberrations
Participants with urothelial cancer (UC) will be evaluated for the prevalence of positive results of selected fibroblast growth factor receptor (FGFR) aberrations and will be assessed for eligibility status for erdafitinib studies. The primary data source for this study will be the medical records of each participant.
Other: Archival Tumor Tissue Sample
Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.




Primary Outcome Measures :
  1. Percentage of Participants with Urothelial Cancer (UC) [ Time Frame: Approximately 1.3 years ]
    Percentage of participants with UC will be assessed through molecular testing of their archival tumor tissue.

  2. Percentage of Participants with Selected Fibroblast Growth Factor Receptor (FGFR) Aberrations [ Time Frame: Approximately 1.3 years ]
    Percentage of participants with selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with urothelial cancer (UC) and selected fibroblast growth factor receptor (FGFR) aberrations.
Criteria

Inclusion Criteria:

  • Transitional cell carcinoma of the urothelium. Minor components (less than [<] 50 percent overall) of variant histology are acceptable
  • Diagnosis of either: a) Metastatic or surgically unresectable urothelial cancer (UC) (Stage IV), b) localized surgically-resectable or resected UC with a T classification of T2 or above who are at high risk for progression to advanced disease as assessed by the investigator
  • Available archival tissue sample for fibroblast growth factor receptor (FGFR) aberration analysis. The archived tissue must either be from 1) metastatic site, 2) localized UC specimen that includes muscle invasive disease (T2 or above)
  • Eastern Cooperative Oncology Group performance status of 0 to 2

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955913


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Show Show 135 study locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03955913    
Other Study ID Numbers: CR108627
42756493BLC0002 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action