Phase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors
Jimeno A, Weiss GJ, Miller WH, Gettinger S, Eigl BJ, Chang AL, Dunbar J, Devens S, Faia K, Skliris G, Kutok J, Lewis KD, Tibes R, Sharfman WH, Ross RW, Rudin CM. Phase I Study of the Hedgehog Pathway Inhibitor IPI-926 in Adult Patients with Solid Tumors. Clinical Cancer Research 2013, 19: 2766-2774. PMID: 23575478, PMCID: PMC3694426, DOI: 10.1158/1078-0432.ccr-12-3654.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAlanine TransaminaseAlopeciaArea Under CurveAspartate AminotransferasesDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleFollow-Up StudiesHedgehog ProteinsHumansMaleMetabolic Clearance RateMiddle AgedNauseaNeoplasmsSignal TransductionSpasmTreatment OutcomeVeratrum AlkaloidsConceptsBasal cell carcinomaDose-limiting toxicityInhibitor-naïve patientsIPI-926Alanine aminotransferaseSolid tumorsAspartate aminotransferaseAccelerated titration scheduleDose-escalation cohortsPhase II doseResponse Evaluation CriteriaSingle-agent activityHuman phase ISolid Tumors assessmentHematologic toxicityStarting doseAdult patientsStandard therapyMuscle spasmTitration scheduleReversible elevationCell carcinomaQD dosingTumor assessmentPharmacokinetic profile