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CTKI258A2210 NEWSLETTER

Amulticenter,randomized,doubleblind,placebocontrolled,phaseIItrialofDovitinib(TKI258)
combinedwithfulvestrant,inpostmenopausalpatientswithHER2andHR+breastcancerthat
haveevidenceofdiseaseprogressiononorafterpriorendocrinetherapy
IN THIS ISSUE
Introduction
Reminder:ExtensionofRecruitment
GlobalStudyStatus
SummaryofEnrollmentStatus
AEManagementRecommendations
DrugSupplyManagement
ERT(CentralECG)
ShipmentofScanstoBioClinica
VendorsCorner
Issue17
January2014
R Re em mi in nd de er r: :
E Ex xt te en ns si io on n o of f R Re ec cr ru ui it tm me en nt t
PreviousTimelines
Updated
Timelines
FPFV(startof
recruitment)
19Apr2012 19Apr2012
LPFV(endof
recruitment)
27Feb2014
27Feb2015
Durationof
Recruitment
22months
34months
FPFV:FirstPatientFirstVisit(Mol.ScreeningICFsigned)
LPFV:LastPatientLastVisit(Mol.ScreeningICFsigned)
CTKI258A2210NewsletterIssue17January2014
H Ha ap pp py y N Ne ew w Y Ye ea ar r 2 20 01 14 4! !
Thisyearstartedverywell!InJanuary,31patientsmolecularly
screened;4ofthemareFGFamplifiedandshouldberandomized
hopefullysoon.
Asoftoday,83patientshavebeenrandomizedin34sites(65FGF
nonamplified=groupclosed,18FGFamplified=groupopen).We
encourageyoutocontinuethemolecularscreeninginorderto
identifyfurtherFGFamplifiedpatients.
Thankstoallsitesteamforallyourefforts!
TheNovartisClinicalTeamCTKI258A2210Study

G Gl lo ob ba al l S St tu ud dy y S St ta at tu us s (asof30Jan2014)

Countries
16
SitesInitiated 59/66
Activesites
atleast1pt.MolScr

55

Inactivesites
5
MolecularScreened 416
MainScreened 93
Randomized
83
FGFnonamplified (NA)
63 Completed(Jan2013)
FGFamplified (A)
18 Target:90pts
Discontinuation* 65(54pts.NA,11pts.A)
SeriousAdverseEvents
42
*Discontinuationreasons:41ptsdiseaseprogression,12pts.Adverse
Event,6ptssubjectdecision(ICFwithdrawal),2pts.death,1Physician
decision,1UNK.
S Su um mm ma ar ry y o of f E En nr ro ol lm me en nt t
( (f fr ro om m J Ja an n- -2 20 01 13 3 t to o J Ja an n- -2 20 01 14 4) )
FGFamplified
From Jan-13
to Jan-14
Molecularly
Screened
FGF amplified
Randomized
USA 81 2
France 55 3
Taiwan 50 0
Hungary 32 1
Italy 16 1
Netherlands 14 0
Argentina 9 0
Peru 9 0
Spain 7 0
Russia 8 2
South Africa 6 0
Austria 5 0
Belgium 4 0
Total 296 9

A Ad dv ve er rs se e E Ev ve en nt ts s M Ma an na ag ge em me en nt t R Re ec co om mm me en nd da at ti io on ns s
EarlypatienteducationregardingthepotentialsideeffectshasbeenshowntoeasesafetymanagementtoDovitinib.
Gastrointestinaltoxicities(nausea,vomiting,anddiarrhea)arethemostcommonreportedtoxicitiesandthemainreasonfor
treatmentdiscontinuation,eveniftheyaregenerallygrade1or2andpotentiallymanageable.
Amoreaggressiveuseofantiemetics,antidiarrheals,foodintake,thenewtabletformulation,anddoseswitchingfrommorningto
nightafterPKevaluation(W3D1,W4D5,W5D1andW6D5)areexpectedtoimprovegastrointestinaltolerance.
Closelymonitoringofliverfunctiontestsarehighlyrecommendedduringtherapy.However,observedlivertoxicityissimilartothe
reportedwithothercompoundsofthesameclass.
Followeligibilitycriteria,monitoringanddoseadjustmentguidelinesandtoxicitymanagementguidelines(protocoltable63)
Weencourageyoutouseanyavailableandprotocolconformablepharmacologicandnonpharmacologicmeasuretopreventsomeof
thecommonlyobservedadverseeventstoallowpatientstorealizethemaximumbenefitoftreatment.
D Dr ru ug g S Su up pp pl ly y M Ma an na ag ge em me en nt t
TKI258(Dovitinib)/PlacebomatchingTKI
Allsiteshavedrugsexpiringon31Apr2014.
ResupplydeliveryatsiteplannedinFebruary(forpriority
countries)anditwillbecompletedinMarchinallsites.
Prioritycountries:Poland(upcomingsiteinitiations),and
countrieswithpatientsundertreatment:Argentina,Austria,
Belgium,France,Hungary,Italy,Netherlands,RussiaandUS.

Fulvestrant(Faslodex)
Globallysourcedtocountries,exceptforUSsites.
AllsiteshaveenoughFulvestrantsyringestocoverneedsby
endFebruarybeginningofMarch.
Aglobalpurchaseisongoingandnewresupplywillbe
organizedbeginningofMarchasneeded.
REMINDER:INCASEOFURGENTNEED,
PLEASEESCALATETOYOURNOVARTISMONITOR.THANKS!
V Ve en nd do or r s s C Co or rn ne er r
IVRS(randomization,drugsupply)
https://onlineclinphone.com
customercare@perceptive.com
Automaticnotificationemail

FGFamplificationtesting
crc.europe@questdiagnostics.com
Resultsshouldbefaxedwithin5workingdays
fromreceiptofsamples(10workingdaysifre
assay).AnalysiseveryThursday
ONLYforsitesinCOMMONwithBelle2
biopharmPM@genoptix.com
Phone:0017605166092(Allcountries)
Safetylab
investigator.services@quintiles.com
Resultsfaxedwithin24hours
ECG
https://mystudy.ert.com/direct/web/guest/home
customercare@ert.com
Resultsinportalwithin72hours

Imaging
http://siteportal.corelabpartners.com
sitesupport@corelabpartners.com
NCTportal
https://www.nctportal.com/

Note:allvendorshavetollfreenumbersforeachcountry
2 CTKI258A2210NewsletterIssue17January2014
E ER RT T ( (C Ce en nt tr ra al l E EC CG G) ): :
DontforgettoperformtheECGtransmissions!
Tobedonewithin5daysafterthepatientvisit
ECGsshouldbetransmitteddigitally.
Ifthatisnotpossiblepleasesendoriginaltracingsviacourierto
ERT(paperECG).
Any issue with ECG transmission please contact ERT customer
carecustomercare@ert.comandinformtheNovartismonitor
S Sh hi ip pm me en nt t o of f s sc ca an ns s t to o B Bi io oC Cl li in ni ic ca a
D Do on n t t f fo or rg ge et t t to o s se en nd d a al ll l t tu um mo or r a as ss se es ss sm me en nt t s sc ca an ns s t to o B Bi io oC Cl li in ni ic ca a
( (w wo or rk kw wi it th hy yo ou ur ra as ss si ig gn ne ed dM Mo on ni it to or rt to oi id de en nt ti if fy ym mi is ss si in ng gs sc ca an ns s) )
ANYQUESTION?PLEASEDONOTHESITATETOCONTACTTHE
NOVARTISMONITORASSIGNEDTOYOURSITE.
FURTHERINFORMATIONALSOAVAILABLEINNOVARTIS
INVESTIGATORPORTAL:HTTPS://WWW.NCTPORTAL.COM/
THANKS

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