2017
A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors
Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, Patel MR, Domchek SM, Balmaña J, Drew Y, Chen LM, Safra T, Montes A, Giordano H, Maloney L, Goble S, Isaacson J, Xiao J, Borrow J, Rolfe L, Shapira-Frommer R. A Phase I–II Study of the Oral PARP Inhibitor Rucaparib in Patients with Germline BRCA1/2-Mutated Ovarian Carcinoma or Other Solid Tumors. Clinical Cancer Research 2017, 23: 4095-4106. PMID: 28264872, DOI: 10.1158/1078-0432.ccr-16-2796.Peer-Reviewed Original ResearchConceptsHigh-grade ovarian carcinomaObjective response rateInvestigator-assessed objective response rateOral rucaparibAdverse eventsCommon treatment-emergent adverse eventsTreatment-emergent adverse eventsAspartate transaminase elevationsAsthenia/fatigueProtocol-defined criteriaRECIST version 1.1Phase II doseAdvanced solid tumorsProgression-free intervalSmall molecule PARP inhibitorsClin Cancer ResManageable toxicityPrior regimensPrimary endpointTransaminase elevationPlatinum therapyMultiple dosesOvarian carcinomaAlanine transaminaseClinical activity
2015
Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC).
Kang Y, LoRusso P, Salgia R, Yen C, Lin C, Ramanathan R, Kaminker P, Sokolova I, Bhathena A, Wang L, Naumovski L, Strickler J. Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC). Journal Of Clinical Oncology 2015, 33: 167-167. DOI: 10.1200/jco.2015.33.3_suppl.167.Peer-Reviewed Original ResearchAnti-c-Met antibodySingle-agent activityMET amplificationProgressive diseasePartial responseSubstantial single-agent activityGood responsePrimary untreated tumorsRECIST version 1.1Treatment-refractory tumorsDose-escalation phaseHuman xenograft tumorsC-Met overexpressionPrimary tumor tissuesTumor biopsy tissueLonger PFSAdvanced gastricAdverse eventsPrior linesSystemic therapyRecurrent tumorsPatient populationEsophageal cancerPrimary tumorEscalation phase