2019
Challenges and approaches to implementing master/basket trials in oncology
Burd A, Schilsky RL, Byrd JC, Levine RL, Papadimitrakopoulou VA, Herbst RS, Redman MW, Druker BJ, Gandara DR. Challenges and approaches to implementing master/basket trials in oncology. Blood Advances 2019, 3: 2237-2243. PMID: 31337605, PMCID: PMC6650731, DOI: 10.1182/bloodadvances.2019031229.Peer-Reviewed Original ResearchConceptsBasket trialsClinical trial designHealth care providersDifferent tumor typesTherapeutic optionsImmunologic reactionsCare providersDrug development effortsTrial designTumor typesPatientsMost cancersClinical researchNew therapeuticsCancer communityTherapy todayMedical institutionsCancerCancer researchTrialsRare mutationsEpigenetic changesHistologyOncologyAppetite
2010
A Phase I Safety and Pharmacokinetic Study of the Death Receptor 5 Agonistic Antibody PRO95780 in Patients with Advanced Malignancies
Camidge DR, Herbst RS, Gordon MS, Eckhardt SG, Kurzrock R, Durbin B, Ing J, Tohnya TM, Sager J, Ashkenazi A, Bray G, Mendelson D. A Phase I Safety and Pharmacokinetic Study of the Death Receptor 5 Agonistic Antibody PRO95780 in Patients with Advanced Malignancies. Clinical Cancer Research 2010, 16: 1256-1263. PMID: 20145186, DOI: 10.1158/1078-0432.ccr-09-1267.Peer-Reviewed Original ResearchConceptsAdvanced malignanciesGrade 3 transaminase elevationHuman IgG1 monoclonal antibodyPhase I safetyDose-escalation designDose-dependent increaseDeath receptor 5Different tumor typesIgG1 monoclonal antibodyCohort expansionTransaminase elevationI safetyMost patientsObjective responseTrough concentrationsAdverse eventsEscalation designMultiple dosesMinor responseEfficacious concentrationsOvarian cancerEvidence of activityPharmacokinetic analysisReceptor 5Human studies