Part 1 results from NOVA-II, a randomized, double-blind, vehicle-controlled phase II study evaluating the safety and efficacy of OQL011 on VEGFR inhibitor associated hand-foot skin reaction in cancer patients.
Lacouture M, Patel A, LeBoeuf N, Marathe O, Leventhal J, Choi J, Lam E, Kaffenberger B, Voss M, Webb M, Tyler R, Ju J, Tang H, Luo J, Anadkat M, Vogelzang N. Part 1 results from NOVA-II, a randomized, double-blind, vehicle-controlled phase II study evaluating the safety and efficacy of OQL011 on VEGFR inhibitor associated hand-foot skin reaction in cancer patients. Journal Of Clinical Oncology 2022, 40: tps396-tps396. DOI: 10.1200/jco.2022.40.6_suppl.tps396.Peer-Reviewed Original ResearchHand-foot skin reactionPalmar-plantar erythrodysesthesiaProportion of patientsCTCAE v5.0IGA scoreSkin reactionsSevere hand-foot skin reactionMulti-targeted tyrosine kinase inhibitorWeek 3Nitric oxideInvestigator's Global Assessment (IGA) scaleLast patient visitVehicle-controlled trialPhase II studyVisual analog scaleVascular repair mechanismsTyrosine kinase inhibitorsGlobal Assessment ScaleInhibition of VEGFChi-square testIntra-rater reliabilityTopical stimulationTopical ureaPrimary endpointSecondary endpoints