About the PROOF 302 Trial

A Clinical Research Study for Urothelial Carcinoma

The PROOF 302 Trial is a Phase 3, multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral-targeted FGFR1-3 inhibitor, called infigratinib*, as adjuvant treatment following surgery in adult subjects with invasive urothelial carcinoma and susceptible FGFR3 genetic alterations (mutations and gene fusions or translocations [ie, rearrangements]) whose disease is considered at high risk for recurrence with surgery alone. The study enrolls subjects with either bladder cancer, post-radical cystectomy or upper tract urothelial cancer, post-distal ureterectomy, and/or nephrectomy. Study participants will be randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence.

Investigational Medication
(Infigratinib) or
Comparator (Placebo):

Summarized Eligibility Criteria

Inclusion Criteria

  • Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy
  • If the patient received neoadjuvant chemotherapy, pathologic stage at surgical resection must be American Joint Committee on Cancer (AJCC) Stage ≥ypT2 and/or yN+
  • If the patient did not receive neoadjuvant chemotherapy:
    • Must be ineligible to receive cisplatin-based adjuvant chemotherapy per the Galsky criteria:
      • creatinine clearance <60 cc/min or
      • ≥ Grade 2 hearing loss or
      • ≥ Grade 2 neuropathy
    • Pathologic stage must be AJCC Stage ≥pT2 pN0–2 M0 (post-lymphadenectomy or no lymphadenectomy [pNx]) for upper tract disease
    • Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer)
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Patients must have no evidence of metastatic disease based on screening computed tomography (CT) or magnetic resonance imaging (MRI)

Exclusion Criteria

  • Presence of positive surgical margins following nephroureterectomy, distal ureterectomy, or cystectomy
  • Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for non-muscle invasive bladder cancer (NMIBC) within the previous 30 days
  • Have previously or currently is receiving treatment with a mitogen-activated protein kinase (MEK) or selective FGFR inhibitor
  • Have impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (eg, active ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Have current evidence of corneal or retinal disorder/keratopathy
  • Have history and/or current evidence of extensive tissue calcification
  • Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, or tumoral calcinosis), unless well controlled
  • Are currently receiving, or are planning to receive during participation in this study, treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications that increase serum phosphorus and/or calcium concentration
  • Clinically significant cardiac disease
  • Recent (<3 months prior to first dose of study drug) transient ischemic attack or stroke

Additional inclusion and exclusion criteria apply. Patients must meet all eligibility criteria to be considered for the clinical research study.

Find a Participating Site

Clinicaltrials.gov

Find a participating site
at ClinicalTrials.gov.

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