2024
Phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab.
Noonan A, Schnell P, Trunzo D, Thornton W, Malalur P, Manne A, Abushahin L, Rahman S, Jin N, Hays J, Elkhatib R, Mittra A, Roychowdhury S, Lustberg M, Sparreboom A, Hu S. Phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab. Journal Of Clinical Oncology 2024, 42: 745-745. DOI: 10.1200/jco.2024.42.3_suppl.745.Peer-Reviewed Original ResearchOrganic cation transporter 2Serum biomarkersEfficacy biomarkersRecommended phase 2 doseRandomized phase II studySide effect of oxaliplatinRat dorsal root gangliaEarly study discontinuationMFOLFOX6 + bevacizumabPhase 2 doseStudy of dasatinibGastrointestinal (GI) cancersOxaliplatin-induced neuropathyPhase II studyEffect of oxaliplatinPhase I trialDose-finding studyLow intermittent dosesDorsal root gangliaDisabling side effectsDose of DAddition of DFOLFOX chemotherapyFOLFOX regimenStudy discontinuation
2023
A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab.
Noonan A, Farid S, Schnell P, Trunzo D, Malalur P, Jin N, Manne A, Abushahin L, Rahman S, Hays J, Elkhatib R, Mittra A, Roychowdhury S, Lustberg M, Sparreboom A, Hu S. A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with gastrointestinal (GI) cancers receiving FOLFOX chemotherapy with or without bevacizumab. Journal Of Clinical Oncology 2023, 41: e15613-e15613. DOI: 10.1200/jco.2023.41.16_suppl.e15613.Peer-Reviewed Original ResearchOrganic cation transporter 2Efficacy biomarkersRandomized phase II studyRat dorsal root gangliaAmount of oxaliplatinPhase 2 doseOxaliplatin-induced neuropathyPhase II studyPhase I trialDose-finding studyDorsal root gangliaLevels of biomarkersMajority of ptsFOLFOX chemotherapyFOLFOX regimenOX administrationII studyI trialPeripheral neuropathyGastrointestinal cancerGI cancersPreclinical dataRoot gangliaSerum biomarkersCohort 2
2020
A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with metastatic colorectal cancer receiving FOLFOX chemotherapy and bevacizumab.
Noonan A, Lustberg M, Schnell P, Hays J, Jin N, Abushahin L, Malalur P, Roychowdhury S, Elkhatib R, Chen H, Al Mutar S, Sparreboom A, Hu S. A phase Ib adaptive study of dasatinib for the prevention of oxaliplatin-induced neuropathy in patients with metastatic colorectal cancer receiving FOLFOX chemotherapy and bevacizumab. Journal Of Clinical Oncology 2020, 38: tps12125-tps12125. DOI: 10.1200/jco.2020.38.15_suppl.tps12125.Peer-Reviewed Original ResearchOxaliplatin-induced peripheral neuropathyOxaliplatin-induced neuropathyOrganic cation transporter 2Peripheral neuropathyColorectal cancerChronic oxaliplatin-induced peripheral neuropathyStage IV colorectal cancerRat dorsal root gangliaOxaliplatin-induced neurotoxicityPharmacokinetics of oxaliplatinPhase 2 doseMetastatic colorectal cancerPhase 1b trialDose-finding studyDorsal root gangliaAddition of dasatinibQuality of lifeSmall molecule kinase inhibitorsFOLFOX chemotherapyOral dasatinibBevacizumab therapyRoot gangliaSerum biomarkersIntermittent doseRat model
2019
The Global POLAR program: Two pivotal placebo-controlled studies of calmangafodipir used on top of modified FOLFOX6 to prevent chemotherapy-induced peripheral neuropathy (CIPN).
Lustberg M, Pfeiffer P, Qvortrup C, Muro K, Bengtson M, Nittve M, Sonesson C, Nagahama F, Sonehara Y, Carlsson C. The Global POLAR program: Two pivotal placebo-controlled studies of calmangafodipir used on top of modified FOLFOX6 to prevent chemotherapy-induced peripheral neuropathy (CIPN). Journal Of Clinical Oncology 2019, 37: tps3616-tps3616. DOI: 10.1200/jco.2019.37.15_suppl.tps3616.Peer-Reviewed Original ResearchChemotherapy-induced peripheral neuropathyChronic chemotherapy-induced peripheral neuropathyMetastatic colorectal cancerProportion of patientsFree survivalSafety endpointCumulative doseHigh-risk stage IIAdditional safety endpointsProgressive-free survivalCommon adverse eventsPlacebo-controlled studyDisease-free survivalOxaliplatin-induced neuropathyTreatment of patientsManganese superoxide dismutase activitySuperoxide dismutase mimeticFOLFOX6 chemotherapyMFOLFOX6 chemotherapyOXA treatmentPrimary endpointAdverse eventsFirst doseOverall survivalMS patientsThe Global POLAR program: Calmangafodipir used on top of modified FOLFOX6 (5-FU/FA and oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN).
Pfeiffer P, Qvortrup C, Muro K, Lustberg M, Nagahama F, Sonehara Y, Bengtson M, Nittve M, Sonesson C, Carlsson C. The Global POLAR program: Calmangafodipir used on top of modified FOLFOX6 (5-FU/FA and oxaliplatin) to prevent chemotherapy induced peripheral neuropathy (CIPN). Journal Of Clinical Oncology 2019, 37: tps722-tps722. DOI: 10.1200/jco.2019.37.4_suppl.tps722.Peer-Reviewed Original ResearchMetastatic colorectal cancerProportion of patientsFree survivalSafety endpointCumulative doseHigh-risk stage IIAdditional safety endpointsProgressive-free survivalCommon adverse eventsOxaliplatin-induced neuropathyDisease-free survivalPatient reported symptomsTreatment of patientsManganese superoxide dismutase activitySuperoxide dismutase mimeticFOLFOX6 chemotherapyMFOLFOX6 chemotherapyOXA treatmentPrimary endpointAdverse eventsFirst doseOverall survivalMS patientsPeripheral neuropathyTreatment breaks