2013
A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer
Liu JF, Tolaney SM, Birrer M, Fleming GF, Buss MK, Dahlberg SE, Lee H, Whalen C, Tyburski K, Winer E, Ivy P, Matulonis UA. A Phase 1 trial of the poly(ADP-ribose) polymerase inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cediranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer. European Journal Of Cancer 2013, 49: 2972-2978. PMID: 23810467, PMCID: PMC3956307, DOI: 10.1016/j.ejca.2013.05.020.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCapsulesCarcinoma, Ovarian EpithelialDiarrheaDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleHumansMiddle AgedNauseaNeoplasm Recurrence, LocalNeoplasms, Glandular and EpithelialOvarian NeoplasmsPhthalazinesPiperazinesPoly(ADP-ribose) Polymerase InhibitorsQuinazolinesReceptor, ErbB-2Receptors, EstrogenReceptors, ProgesteroneReceptors, Vascular Endothelial Growth FactorTabletsTreatment OutcomeConceptsTriple-negative breast cancerOvarian cancer patientsOverall response rateCombination of cediranibCancer patientsBreast cancerDose levelsMetastatic triple-negative breast cancerEvaluable breast cancer patientsPARP inhibitorsClinical benefit rateGrade 3 fatigueGrade 3 hypertensionPhase 2 dosingVascular endothelial growth factor receptorResponse Evaluation CriteriaSolid Tumors 1.1Endothelial growth factor receptorPhase 1 trialBreast cancer patientsDose-escalation designHighest dose levelPolymerase inhibitor olaparibCA125 criteriaGrowth factor receptor
1994
Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors.
Rowinsky EK, Noe DA, Trump DL, Winer EP, Lucas VS, Wargin WA, Hohneker JA, Lubejko B, Sartorius SE, Ettinger DS. Pharmacokinetic, bioavailability, and feasibility study of oral vinorelbine in patients with solid tumors. Journal Of Clinical Oncology 1994, 12: 1754-63. PMID: 8083697, DOI: 10.1200/jco.1994.12.9.1754.Peer-Reviewed Original ResearchConceptsMaximum-tolerated doseOral administrationOral formulationOral vinorelbineGrade 3Large first-pass effectLower starting doseSemisynthetic vinca alkaloidChronic oral administrationHepatic blood flowPhase II evaluationPharmacokinetic studyDivided-dose scheduleMaximum plasma concentrationFirst-pass effectSteady-state volumeGelatin capsulesPlasma drug dispositionPharmacologic exposuresPrincipal toxicityStarting doseDose escalationOral dosesOral doseCancer patients