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PhII Study of JNJ-42756493 in Pts w/Met or Surgically Unresect UC w/FGFR Genomic Alterations

Daniela Bota


A Study On:

  • Urinary Bladder

Status:

  • Open

Eligibility

Adults

Interested in joining this trial?

Official Title

Drug-Drug Interaction Substudy to Assess the Effect of Repeated Doses of Erdafitinib on the Single-dose Pharmacokinetics of Midazolam and Metformin in Subjects with Advanced Solid Tumors that Harbor Target FGFR Mutations or FGFR Gene Fusions at Selected Sites conducted under main study, "A Phase II, Two-Arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regiments of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metastatic or Surgically Unresectable Urothelial Cancer with FGFR Genomic Alterations

Details

The purpose of this study is to evaluate the objective response rate (complete response [CR]+ partial response [PR]) of the selected dose regimen in participants with metastatic or surgically unresectable urothelial cancers that harbor specific FGFR genomic alterations.


Eligibility

You can join if...

Inclusion Criteria:

  • Histological demonstration of an unresectable, locally advanced, or
    metastatic solid tumor malignancy
  • Adequate bone marrow, liver, and renal function as described by the study protocol
  • Patients have to agree to use acceptable contraceptive methods as described by the protocol

Exclusion Criteria:

  • Treatment with any other investigational agent in another clinical study within 30 days
    prior to randomization
  • History of uncontrolled cardiovascular disease(s) as described by the study protocol
  • Impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers,
    known gastric ulcers, or unhealed incisions

Get in touch with our study team