Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial of Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations (PROOF 302)
Condition: Upper Tract Urothelial Carcinomas, Urothelial Bladder Cancer
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT04197986
Sponsor: QED Therapeutics, Inc.
Phase: Phase 3
- Age: minimum 18 Years maximum N/A
- Gender: All
- 1. Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations within 120 days following nephroureterectomy, distal ureterectomy, or cystectomy 2. If the patient received neoadjuvant chemotherapy, pathologic stage at surgical resection must be AJCC Stage ≥ ypT2 and/or yN+. 3. If the patient did not receive neoadjuvant chemotherapy: 1. Must be ineligible to receive cisplatin-based adjuvant chemotherapy per the Galsky criteria:
- creatinine clearance < 60cc/min or
- ≥ Grade 2 hearing loss or
- ≥ Grade 2 neuropathy) 2. Pathologic stage must be AJCC Stage ≥pT2 pN0-2 M0 (post-lymphadenectomy or no lymphadenectomy [pNx]) for upper tract disease. 3. Pathologic stage should be AJCC Stage ≥pT3 or pN+ (bladder cancer). 4. Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2. 5. Patients must have no evidence of metastatic disease based on screening CT or MRI.
- 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, small bowel resection)
- Have current evidence of corneal or retinal disorder/keratopathy.
- Have a 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, 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 which 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.
View trial on ClinicalTrials.gov