Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial.
Sumanta Kumar PalDiederik M SomfordPetros GrivasSrikala S SridharShilpa GuptaJoaquim BellmuntGuru SonpavdeMark T FlemingSeth P LernerYohann LoriotJean Hoffman-CensitsBegoña P ValderramaCorina AndresenMarco J SchnabelSuzanne ColeSiamak DaneshmandPublished in: Future oncology (London, England) (2022)
PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.
Keyphrases
- phase iii
- placebo controlled
- double blind
- open label
- free survival
- clinical trial
- phase ii
- end stage renal disease
- newly diagnosed
- chronic kidney disease
- ejection fraction
- study protocol
- prognostic factors
- early stage
- minimally invasive
- physical activity
- squamous cell carcinoma
- peritoneal dialysis
- patient reported outcomes
- oxidative stress
- randomized controlled trial
- radiation therapy
- drug delivery
- acute coronary syndrome
- rectal cancer