Antitumour activity of MDV3100 in castration‐resistant prostate cancer: a phase 1–2 study

Antitumour activityofMDV3100
incastration‐resistant
prostatecancer:aphase1–2
study
Scher HI,Lancet,Vol 375April24,2010

Objectifs
Principal
•SafetyandtolerabilityprofileofMDV3100
•Toestablishthemaximumtolerated dose(MTD)
Secondaire
•Antitumour effects :PCWG2

Population
•Diagnosisofprostatecancer,histologically
confirmed
•Progressivecastrationresistantdisease:
•castrate concentrationsoftestosterone (<1.7nmol/L),
•ANDrisingPSA
•withorwithoutdetectablemetastases.

Schémad’escaladededose3+3
PhaseI:1er ptdelacohortetraitéàJ1,observé6jourspuispriseencontinue
EvaluationdestoxicitésàJ28
PhaseII:Dufaitdelaréponsebiologiquedes6erspts:
extensiondetouteslescohortesde60à360mgde24patients
suplémentaires

Suividestoxicités
CritèresNCICTCAEVERSION3.0