This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study to evaluate the efficacy of giving an oral targeted FGFR1-3 inhibitor, 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) who have disease that 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 treatment is randomized between infigratinib or placebo with treatment until invasive local or distal disease recurrence.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||March 11, 2020||Phase 3||Interventional|
Primary Outcome 1 - Measure: Centrally determine disease-free survival (DFS)
Primary Outcome 1 - Time Frame: Randomization through 1 year after end of treatment
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
- 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.
1. Presence of positive surgical margins following nephroureterectomy, distal
ureterectomy, or cystectomy.
2. Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for
Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.
3. Have previously or currently is receiving treatment with a mitogen-activated protein
kinase (MEK) or selective FGFR inhibitor.
4. 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
5. Have current evidence of corneal or retinal disorder/keratopathy.
6. Have a history and/or current evidence of extensive tissue calcification.
7. Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg,
parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis),
unless well controlled.
8. 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.
9. Clinically significant cardiac disease.
10. Recent (< 3 months prior to first dose of study drug) transient ischemic attack or
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Corina Andresen, MD
Role: Study Director
Affiliation: QED Therapeutics
Name: QED Therapeutics
|Arizona Oncology Associates
Tucson, Arizona 85711
|City of Hope
Duarte, California 91010
Sumanta Pal, M.D.
|Woodlands Medical Specialist
Pensacola, Florida 32503
|Oncology Hematology Care
Cincinnati, Ohio 45242
|Urology Associates, P.C.
Nashville, Tennessee 37209
Longview, Texas 75601