PhaseICancerClinicalTrials1PhaseICancerClinicalTrialsAPracticalGuideSECONDEDITIONnEDITEDBYELIZABETHA.EISENHAUERCHRISTWELVESMARCBUYSE1OxfordUniversityPressisadepartmentoftheUniversityofOxford.ItfurtherstheUniversity’sobjectiveofexcellenceinresearch,scholarship,andeducationbypublishingworldwide.OxfordNewYorkAucklandCapeTownDaresSalaamHongKongKarachiKualaLumpurMadridMelbourneMexicoCityNairobiNewDelhiShanghaiTaipeiTorontoWithofficesinArgentinaAustriaBrazilChileCzechRepublicFranceGreeceGuatemalaHungaryItalyJapanPolandPortugalSingaporeSouthKoreaSwitzerlandThailandTurkeyUkraineVietnamOxfordisaregisteredtrademarkofOxfordUniversityPressintheUKandcertainothercountries.PublishedintheUnitedStatesofAmericabyOxfordUniversityPress198MadisonAvenue,NewYork,NY10016©OxfordUniversityPress2015Allrightsreserved.Nopartofthispublicationmaybereproduced,storedinaretrievalsystem,ortransmitted,inanyformorbyanymeans,withoutthepriorpermissioninwritingofOxfordUniversityPress,orasexpresslypermittedbylaw,bylicense,orundertermsagreedwiththeappropriatereproductionrightsorganization.InquiriesconcerningreproductionoutsidethescopeoftheaboveshouldbesenttotheRightsDepartment,OxfordUniversityPress,attheaddressabove.Youmustnotcirculatethisworkinanyotherformandyoumustimposethissameconditiononanyacquirer.LibraryofCongressCataloging-in-PublicationDataPhaseIcancerclinicaltrials:apracticalguide/editedbyElizabethA.Eisenhauer,ChrisTwelves,MarcBuyse.—Secondedition.p.;cm.PrecededbyPhaseIcancerclinicaltrials:apracticalguide/ElizabethA.Eisenhauer,ChristopherTwelves,MarcBuyse.1sted.2006.Includesbibliographicalreferencesandindex.ISBN978–0–19–935901–1(alk.paper)I.Eisenhauer,ElizabethA.,editor.II.Twelves,Chris,editor.III.Buyse,MarcE.,editor.IV.Eisenhauer,ElizabethA.PhaseIcancerclinicaltrials.[DNLM:1.Neoplasms—therapy.2.ClinicalTrials,PhaseIasTopic—methods.QZ266]RC267616.99′400724—dc232014034346Thismaterialisnotintendedtobe,andshouldnotbeconsidered,asubstituteformedicalorotherprofessionaladvice.Treatmentforth...
