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Brief Title An Efficacy and Safety Study of JNJ-42756493 in Participants With Urothelial Cancer
Official Title A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations
Principal Investigator O'Donnell, Peter
Brief Summary The purpose of this study is to evaluate the objective response rate of the selected dose regimen out of 2 possible dose regimens of JNJ-42756493 in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.
Gender Both
Ages 18 Years
Enrollment 165
Accepts Healthy Volunteers No
Lead Sponsor Janssen Research & Development, LLCIndustry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Urothelial Cancer
Detail for Health Professional (on clinicaltrials.gov)
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