2014
55P PET/CT Imaging of 64CU-Labelled HER2 Liposomal Doxorubicin (64CU-MM-302) Quantifies Variability of Liposomal Drug Delivery to Diverse Tumor Lesions in HER2-Positive Breast Cancer Patients
Hendriks B, Shields A, Siegel B, Miller K, Munster P, Ma C, Campbell K, Moyo V, Wickham T, LoRusso P. 55P PET/CT Imaging of 64CU-Labelled HER2 Liposomal Doxorubicin (64CU-MM-302) Quantifies Variability of Liposomal Drug Delivery to Diverse Tumor Lesions in HER2-Positive Breast Cancer Patients. Annals Of Oncology 2014, 25: i19. DOI: 10.1093/annonc/mdu068.1.Peer-Reviewed Original Research
2013
A phase I study of birinapant (TL32711) combined with multiple chemotherapies evaluating tolerability and clinical activity for solid tumor patients.
Amaravadi R, Senzer N, Martin L, Schilder R, LoRusso P, Papadopoulos K, Weng D, Graham M, Adjei A. A phase I study of birinapant (TL32711) combined with multiple chemotherapies evaluating tolerability and clinical activity for solid tumor patients. Journal Of Clinical Oncology 2013, 31: 2504-2504. DOI: 10.1200/jco.2013.31.15_suppl.2504.Peer-Reviewed Original ResearchCarboplatin/paclitaxelDose-limiting toxicityLiposomal doxorubicinMultiple chemotherapyDose escalationClinical benefitExcellent tolerabilityClinical activityClinical studiesRefractory solid tumorsPhase 1 studySolid tumor patientsFurther clinical studiesAnti-tumor synergyHighest dose levelNotable clinical activityApoptotic pathway activationG regimenStable diseaseStandard dosingProgressive diseasePartial responseBell's palsyTolerable combinationReversible toxicity
2012
A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer.
Munster P, Miller K, Krop I, Dhindsa N, Reynolds J, Geretti E, Niyikiza C, Nielsen U, Hendriks B, Wickham T, Moyo V, LoRusso P. A phase I study of MM-302, a HER2-targeted liposomal doxorubicin, in patients with advanced, HER2-positive (HER2+) breast cancer. Journal Of Clinical Oncology 2012, 30: tps663-tps663. DOI: 10.1200/jco.2012.30.15_suppl.tps663.Peer-Reviewed Original ResearchAdvanced breast cancerMaximum feasible doseBreast cancerMM-302Liposomal doxorubicinHER2-positive breast cancerTumor cellsAdequate performance statusAnthracycline-free regimensBone marrow reserveDose-escalation portionClinical benefit rateDose-limiting toxicityDose-escalation designHER2-positive cancersPreliminary efficacy dataHuman phase IStandard therapy existsBreast cancer therapyAvailable anthracyclinesPrimary endpointSecondary endpointsMarrow reservePerformance statusStandard therapyClinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens.
Fetterly G, Liu B, Senzer N, Amaravadi R, Schilder R, Martin L, LoRusso P, Papadopoulos K, Adjei A, Zagst P, McKinlay M, Weng D, Graham M. Clinical pharmacokinetics of the Smac-mimetic birinapant (TL32711) as a single agent and in combination with multiple chemotherapy regimens. Journal Of Clinical Oncology 2012, 30: 3029-3029. DOI: 10.1200/jco.2012.30.15_suppl.3029.Peer-Reviewed Original ResearchPaclitaxel/carboplatinMultiple chemotherapy regimensChemotherapy regimensWeekly dosingInterpatient variabilityLiposomal doxorubicinPK modelDose-proportional kineticsModerate interpatient variabilityPopulation PK modelPopulation PK modelingSMAC mimetic birinapantBlockade of apoptosisAdvanced malignanciesCombination regimensConcomitant administration