2019
First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors
Piha-Paul SA, Sachdev JC, Barve M, LoRusso P, Szmulewitz R, Patel SP, Lara PN, Chen X, Hu B, Freise KJ, Modi D, Sood A, Hutti JE, Wolff J, O'Neil BH. First-in-Human Study of Mivebresib (ABBV-075), an Oral Pan-Inhibitor of Bromodomain and Extra Terminal Proteins, in Patients with Relapsed/Refractory Solid Tumors. Clinical Cancer Research 2019, 25: 6309-6319. PMID: 31420359, DOI: 10.1158/1078-0432.ccr-19-0578.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsDose escalationSolid tumorsStable diseaseSafety profileProstate cancerCommon grade 3/4 treatment-emergent adverse eventsGrade 3/4 treatment-emergent adverse eventsHuman studiesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsMedian progression-free survivalTolerable safety profilePhase II doseAdvanced solid tumorsProgression-free survivalRefractory solid tumorsPreliminary antitumor activityMalignant solid tumorsAminotransferase elevationEvaluable patientsDose expansionExpansion cohortGastrointestinal bleedAdverse events
2015
Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors.
Wang D, Braiteh F, Lee J, Denlinger C, Shepard D, Chaudhary A, Lin Y, Gao L, Asakiewicz C, Nasroulah F, LoRusso P. Phase II study evaluating the effect of concomitant ramucirumab (RAM) on the pharmacokinetics (PK) of irinotecan (IRI) and its metabolite SN-38 when coadministered with folinic acid (FA) and 5-fluorouracil (5-FU) (FOLFIRI) in patients (pts) with advanced malignant solid tumors. Journal Of Clinical Oncology 2015, 33: 691-691. DOI: 10.1200/jco.2015.33.3_suppl.691.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdvanced malignant solid tumorsPharmacokinetics of irinotecanMalignant solid tumorsMetabolite SN-38Folinic acidSN-38Safety populationStandard therapyEastern Cooperative Oncology Group performance statusSolid tumorsCycle 1Maximum observed drug concentrationFatigue/astheniaPhase II studyKey eligibility criteriaDose-normalized areaNew safety concernsC maxII studyPerformance statusAdverse eventsStudy treatmentIntravenous infusionPlasma concentrations