`
`Arc!t;.YC
`
`! Current version of
`H},,'1.:§iew of NCT00417079 on 2005 12 28
`NCT00417079
`2006 12 28
`
`Updated:
`
`/'.
`
`(
`
`Descriptive Information
`XRP6258 Plus Prednisone Cornpared to iviit-oxantrone Pius
`Brief title
`Predntsone in Hormone Refractory ivletastatic Prostate
`Cancer OkOPie)
`Randomized, Open Label Multi-Center Study of XRP6253
`in Combination \Nith Prednisone Compmed to Mitoxantrone
`in Combination With Prednisone For The Treatment of
`Horrnone Rofroctory Metastatic Prostate Cancer Previously
`Treated With A Toxotere®-Containing Regimen
`
`Officill! title
`
`Br-ief SUrBi"nary
`Tills IS a randorl1ized, open-label, muiti-center stUdy cornparing till:: safety and
`efficacy of XRP6258 pius prednisone to mitoxantronE! plus prednisone in the
`treatrnent of honnone' refractory
`prostate cancer previously treated
`with a Taxotere-containing regnnen, The primary objective is overaii survival,
`Secondary objectives include progression free survivaL overaii response rat,,>,
`prostate-specific antigen (PSA) response/progression, pain
`response/progression, overall safety, and pllarrn£.."Jcoldnetics. Patients iNHi be
`treated until disease progression, death, unacceptable toxicity, or for t1 maximum
`of 1 () cycles. Patients \ivB! have
`follow--up for <) Inaximurn ot' up to 2
`yeafs.
`
`Phase
`Study type
`Study design
`Study
`Study >:.'1esign
`Study design
`Study design
`Study design
`Primary outcome
`Secondary outcome
`
`Secondary (.)utcornH
`Secondary outcome
`Condition
`CQndiHon
`intervention
`lJRL
`
`P!13se 3
`Interventional
`Tp:)atn1eflt
`
`Open L.abel
`Active Contff)l
`Assignrnel1t
`Efficacy Study
`
`N2Dplasrns
`Neop!asn)s
`
`Drug:
`ITttp:!fWWW.sanofi-f.lVentis.com
`
`ht1p:/;'<.Jinicaltrids,gov/archivc/NCTOO·417079/}.006 12 28
`
`AVENTIS EXHIBIT 2100
`Mylan v. Aventis, IPR2016-00712
`
`
`
`See also
`
`--------------.----
`
`Kecruitment inforrnation
`Status
`Recruiting
`Start date
`2006-12
`Criteria
`inclusion Criteria
`1. Histologically or cytologically cDnfirmed adenocarcinoma of the prostat,,_
`2. Docunlented progression of disease (demonstratlng at least one viscera! (:Ii
`soft tissue metastatic lesion, including a new lesion)_ Patients with non--
`rneasurable disease !l1USt have documented rising PSf\ ievels or
`of
`nevv lesion.
`3_ Surgical or hormone--induced castration
`4 _ Life expectancy> 2 months
`5. Eastern Cooperative Oncology Group (EeOG) perforn-lance status 0 -- 2
`Exclusion criteria
`1 . Previous treatrnent with nl!toxantrone
`2, Phor radiotherapy to ;? 400:/0 .of bone nlarrow
`3. Surgery, radiation, chernotherapy, or other anti-cancer therapy viithln -4 weeks
`prior to enrollment in the study
`4, Othel prior rna!!gnancy, except for adequately treated superficial basal cell
`skin cancer, or any other cancer fran1 which the patlcnt has been
`iess than 5 years
`5. Known brain or leplornenlngea! lnvolvernent
`6,
`concurrent serious lHness or !TIediGai conditions
`7. Inadequate organ function evidenced bV unacceptable laboratory results
`The invt?stigal{)f wiH evaluate vJhether there are other re8sons why a patient
`not participate
`
`for
`
`voiunteen:';
`
`13 Yean;
`No
`
`Orqanization name
`Orgm1iz"tion study iD
`
`Sponsor
`Health Authority
`Hoa!th Authority
`
`Health Authority
`
`Sanofi-i\veniis
`EFCe'!93
`XHP6258
`Sanofi-P>,vcntis
`United States: Food and Drug AdrninistrDtion
`United Kln9dorn: Medicines and Heaithcare Products
`Hegulatory Agency
`Canada.:
`Canada
`
`)8
`
`OL'08/70
`
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