raised for VITAl efacy concerns prompted a futility analys which revealed that the trial had only a 0 chance of meeting an improved survival end-point. Bio Sante nisoldipine Pharmaceuticals acquired GVAX immuno-therapy for prostate cancer when it bought Cell Genesys in . Ongoing discussions with the Food and Drug Administration since that time have resulted in a recent lift on the prior hold over clinical trials for this product. A phase III trial was designed topare the ef acy and safety of MDV versus placebo in patients with mCRPC previously treated with docetaxel-based chemotherapy.
This study was std early when a pre-planned interim analysis showed a significant overall survival bene in the MDV arm: median overall survival was versus months in the placebo arm. A full analysis of the AFFIRM resul including safety da is still to be published.In acipimox addition to two further phase II studie the PREVAIL trial is underway at the time of writing and will evaluate the utility of this agent in chemotherapy-naive mCRPC patients. 3 Orteronel Like abiratero TAK is a selective inhibitor of androgen biosynthesis. In preclinical studies TAK has been shown to bind to and inhibit the enzyme 7, 0-lyase offering potent inhibition of androgen syn-thesis. 3 Phase II and III studies are currently recruiting Table MD 1 current clinical trials in prostate cancer Trial phase and Patients Status start and Trial ID NC 0 Intervention MDV design Phase open lab single-a characteristics Hormone-naive prostate cancer Primary oue Proportion of subjects with a PSA response end date Recruiting Start: Apr multi-center End: Dec NC 9 MDV vs bicalutamide Phase randomiz parallel gro mCRPC chemotherapy-naive Progression-free Lopinavir 192725-17-0 survival Recruiting Start: Feb double blind End: Jan NC 9 MDV vs placebo Phase I randomiz parallel gro double bli mCRPC chemotherapy-naive Overall surviv progression-free survival Recruiting Start:
Sep End: Sep placebo-controll multi-center End date = estimated primarypletion date and denotes al data collection date for primary oue measure. mCR metastatic castration-resistant prostate cancer; P prostate-speci antigen. Blackwell Publishing Asia Pty Ltd Asia “Pac J Clin Onco. : Emerging therapies for mCRPC Table Orteronel : current clinical trials in prostate cancer Patients 9 Status start and Trial ID Interventions Trial phase and design buy Fesoterodine characteristics Primary oue end date NC 2 Orteronel PDN Phase I randomiz mCRPC Overall surviv Recruiting vs placebo PDN parallel gro double chemotherapy-progression-free Start: Oct bli placebo-naive survival End: Jan controll multi-centre NC 2 Orteronel PDN vs placebo PDN Phase I randomiz parallel gro double bli placebo-mCRPC prior treatment with docetaxel Overall survival Recruiting Start: Nov End: Sep controll multi-center NC 6 Orteronel DOC PDN Phase open lab single group ef acy study mCRPC chemotherapy-naive Pharmacokineti maximum dose and PSA Recruiting Start: Jul End:
Mar response rates NC 9 Orteronel Phase open lab single group ef acy Non-metastatic chemotherapy-naive PSA response rates Recruiting Start: May study End: Mar End date = estimated primarypletion date and denotes al data collection date for primary oue bacteria measure. D docetaxel; metastatic castration-resistant prostate cance.