2019
A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors.
Chong C, Bauer T, Laurie S, Patel M, Yamamoto N, Davenport T, Geng J, Gibson N, Vallaster M, LoRusso P. A phase Ia/Ib, open label, multicenter, dose-escalation study of BI 907828 (MDM2-p53 antagonist) in adult patients with advanced or metastatic solid tumors. Journal Of Clinical Oncology 2019, 37: tps3166-tps3166. DOI: 10.1200/jco.2019.37.15_suppl.tps3166.Peer-Reviewed Original ResearchDose-limiting toxicityMetastatic solid tumorsFirst treatment cycleSolid tumorsEvaluable patientsPrimary endpointTreatment cyclesPhase 1bPreliminary anti-tumor activityMDM2-p53 antagonistsNon-squamous NSCLCDose-escalation studyDose-escalation trialSoft tissue sarcomasNumber of patientsTP53 wild-type statusWild-type statusAnti-tumor activityMDM2 amplification statusTumor protein 53New anti-cancer drugsIA/IBOpen labelRECIST v1.1Brain metastases
2007
Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors
Slapak C, LoRusso P, Mendelson D, Sykes A, De Alwis D, Wagner M, Ilaria R, Gordon M. Phase I study of LY573636-sodium, an acylsulfonamide anti-cancer compound with a novel mechanism of action, administered as 24-hour continuous infusion in patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 2542-2542. DOI: 10.1200/jco.2007.25.18_suppl.2542.Peer-Reviewed Original ResearchAnti-cancer compoundsStable diseaseLower total plasma clearanceNovel anti-cancer compoundsGrade 3 hyperbilirubinemiaGrade 4 leukopeniaMaintenance dose regimenGrade 4 thrombocytopeniaAdvanced solid tumorsPhase 2 studyPhase 1 studyContinuous intravenous infusionPhase I studiesSoft tissue sarcomasTotal plasma clearanceCommon DLTDose cohortsDose regimenAlbumin-bound drugsMedian ageTerminal eliminationTissue sarcomasContinuous infusionIntravenous infusionBM suppression
1995
Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks
Foster B, LoRusso P, Poplin E, Zalupski M, Valdivieso M, Wozniak A, Flaherty L, Kasunic D, Earhart R, Baker L. Phase I trial of Adozelesin using the treatment schedule of daily × 5 every 3 weeks. Investigational New Drugs 1995, 13: 321-326. PMID: 8824350, DOI: 10.1007/bf00873138.Peer-Reviewed Original ResearchConceptsMinute IV infusionTreatment scheduleM2/dayIV infusionPhase II starting doseRefractory soft tissue sarcomasConsecutive daysPhase IUnique alkylating agentRefractory solid tumorsPhase I trialSoft tissue sarcomasAdditional phase IPreclinical toxicology studiesBroad antitumor activityPotent synthetic analogsAnaphylactoid syndromeStarting doseI trialPartial responseAntitumor responseCumulative myelosuppressionTissue sarcomasTherapeutic dosesCytotoxic treatment