This document provides Karen Kearns' resume summarizing her education, certifications, employment history, professional affiliations, and experience working on various clinical research studies related to rheumatology and osteoarthritis. It lists over 50 studies she has experience with at various clinical research organizations in Washington spanning from 1996 to the present.

1. 1
Karen M. Kearns
646 NE Dawn Rd.
Bremerton, WA 98311
253-831-3423
OFFICE ADDRESS: CHI FranciscanHealthSystem, FranciscanResearchCenter1812 SouthJ St., Tacoma, WA 98405
EDUCATION:
PacificaHighSchool,1980
GardenGrove,CA
LawtonSchool for Medical Assistants,1983
Encino,CA
WesternGovernorsUniversity,BS,ProjectedGraduation March2017
WA
TRAINING and CERTIFICATIONS:
CertifiedClinical ResearchCoordinator,ACRP2002
RegisteredMedical Assistant,AMT1983
HealthCare AssistantLicense,State of WA,1998
CPR TrainingSafetyCourse,CedarResearch,2007
CPR TrainingSafetyCourse,CedarResearch,2009
CPR TrainingSafetyCourse,CedarResearch,2011
CPR TrainingSafetyCourse,PNMG,2013
CPR TrainingSafetyCourse,CHIFranciscan 2015
EMPLOYMENT:
CHI FranciscanHealthSystem Jan2015 – present
Tacoma, WA
Clinical ResearchCoordinator
PacificNeuroscience Medical Group April 2013 – Dec2014
Oxnard,CA
ResearchManager
Tacoma CenterforArthritisResearch,PS January2004 – April 2013
Tacoma, WA
Clinical ResearchManager,LeadClinical ResearchCoordinator
RobertEttlinger,MD May 1998 – January2004
Tacoma, WA
Medical Assistant,Clinical ResearchCoordinator
PacificCoastClinical Coordinators November1996 – May 1998
Tacoma, WA
Clinical ResearchCoordinator,TeamLeader

2. 2
PROFESSIONAL SOCITIES: Associationof ClinicalResearchProfessionals,1997
AmericanMedical Technologies,1983
ONCOLOGYAFFILIATIONS: Cancer Committee MemberatHarrisonHospital
BreastProgram LeadershipCommittee Member
STUDY EXPERIENCE:
Long-termobservational studyof earlyRheumatoidArthritis. UCLA and The Consortiumof PracticingRheumatologist.
A double-blind,placebo-controlled,randomizedcomparisonstudyof the safetyandefficacyof SC-58635 50mg, 100mg,
and 200mg BID and Naproxen500mg BID intreatingthe signsand symptomsof osteopathicof the knee.
Searle #N49-96-02-202
Clinical protocol toevaluate the long-termsafetyof SC-58635 in treatingthe signsandsymptomsof osteoarthritisand
rheumatoidarthritis.
Searle #N49-96-02-024
Double-blind,placebo-controlled,randomizedcomparisonstudyof the efficacyandsafetyof SC-58635 50mg, 100mg,
and 200mg BID and Naproxen500mg BID intreatingthe signsand symptomsof osteopathicof the hip.
Searle #N49-96-02-054
Double-blind,randomized,placebo-controlledstudytocompare the safetyandefficacyof SB-210396 withplaceboin
patientswithactive rheumatoidarthritisnotcurrentlyreceivingDMARDtherapy.
SmithKlineBeecham210396/015
Clinical protocol foramulticenter,double-blind,placebo-controlledcomparisonstudyof the efficacyof SC-58635 200mg
QD versusSC-58634 100mg BID intreatingsignsandsymptomsof osteoarthritisof the knee.
Searle N49-96-20-060
Clinical protocol foradouble-blind,placebo-controlled,randomized,dose-rangingandpilotefficacystudyof SC-65872 in
treatingthe signsandsymptomsof rheumatoidarthritis.
Searle N91-97-02-016
Double-blind,randomized,6arm, parallel-group,dose-finding,double-dummy,multicentercomparisonof sTNFr55-IgG
subcutaneoustoreference treatmentwithoral MTXand theircombinationinpatientswithrheumatoidarthritis.
HoffmanLa Roche BA15362C
RheumatoidarthritisDMARDinterventionandutilizationstudy(RADIUS1)
Immunex 016.0034
Multicenter,randomized,placebo-controlledstudyof safetyanddisease activityof multiple dosesof subcutaneous
rHuIL-10 inpatientswithactive rheumatoidarthritis.
Schering-PloughC97-035
RheumatoidarthritisDMARDinterventionandutilizationstudy.(RADIUS2)
Immunex 106.0035

3. 3
Raloxifene dailyversusalendroateweeklycomparisoninpostmenopausal womenwithosteoporosis.
LillyH3S-US-GGKO
A multicenter,randomized,double-blind,placebo-controlledstudyof the humananti-tnf monoclonal antibodyD2E7in
rheumatoidarthritispatientscurrentlyreceivingtreatmentwithmethotrexate.
Knoll (Abbott) DE019
A randomized,double-blind,double-dummy,parallel-group,multicenterstudytoevaluate andcompare the effectsof
once weeklyalendronate andrisedronate onbone mineral densityinpostmenopausal womenwithosteoporosis.
(Fosamax Actonel ComparisonTrial –FACT) Merck & Co.,Inc.,MK-0217
A randomized,double-blind,active-comparator-controlled,parallel-groupstudytoevaluate the safetyof etoricoxibin
patientswithosteoarthritisorrheumatoidarthritis.
Merck & Co., Inc.,066-00
An international,multicenter,stratified,randomized,double-blind,double-dummy,parallel-group,52-week
gastrointestinal clinical safetystudytodemonstrate thatCOX189 (400mg od) reducesthe risktodevelopcomplicated
ulcersas comparedto NSAIDs(Naproxen500mg BID andIbuprofen800mg TID) inosteoarthritispatients.
NovartisCCOX189A2332 (TARGET studypart II)
A randomized,double-blind,placebo-controlled,dose-rangingstudytoevaluate the safetyandefficacyof weeklyfixed
dosesof IL-1 Trap inpatientswithactive rheumatoidarthritis.
RegeneronIL1T-RA-0102
A phase II,randomized,double-blind,placebo-controlled,parallel-group,multicenterclinical trial evaluatethe safety
and efficacyof three dosesof LAS34475 vs.placeboandNaproxen500mg BID inpatientswith osteoarthritisof the knee.
Almirall ProdesfarmaM/34475/21
A prospective,open-label,multicenter,two-partstudytoinvestigate patientsatisfactionwithmonthlydosed
ibandronate therapyinwomenwithpostmenopausalosteoporosisorosteopeniatransitionedfromonce-weekly
alendronate orrisidronate.
Roche ML18056
A prospective,open-label,multicenter,studytoevaluatethe change inbone turnovermarkersafteronce monthlyoral
ibandronate therapyintreatmentnaivepostmenopausal osteoporosispatients.
Roche ML18057
A 52-week,international,multicenter,randomized,double-dummy,parallel-groupclinical trial tocompare retentionon
treatment,safetyandtolerability,andefficacyof Lumiracoxib100mgBID and Celecoxib200mgod inpatientswith
primaryosteoarthritisof the hip,knee,handorspine.
NovartisCCOX189A2369
A 26-week,randomized,placeboandactive comparatorcontrolled,parallel-group,double-blind,2-partstudytoassess
the safetyandefficacyof Etoricoxib30mg vs.Celecoxib200mginpatientswithosteoarthritis.
Merck LaboratoriesMK-0663, Protocol 076
A 39-weekopen-labelextensiontoCCOX189A2360, a 13-weekmulticenter,randomizeddouble-blind,double-dummy,
placebo-controlled,paralleltrial od2 differentregimensof lumiracoxib(100mgodand 200 mgod initial dose fortwo
weeksfollowedby100mg od),as a comparator.
NovartisCCOX189A23601E

4. 4
A phase IIIpivotal,multicenter,double-blind,randomized,placebo-controlledmonotherapystudyof milnacipranfor
treatmentof fibromyalgia.
CypressBioscience,Inc.,FMS-031
A phase 4 study:Humira Efficacy Response Optimizationstudyinsubjectswithactive rheumatoidarthritis(HERO)
AbbottM04-684
Open-label extensiontreatmentwithTNFR:FcforparticipatingpatientsinTNFR:Fc clinical trials.
Immunex 016.0018
A multicenter,randomized,double-blind,placebo-controlledstudyof the humananti-tnf monoclonal antibodyD2E7in
rheumatoidarthritispatientscurrentlyreceivingtreatmentwithMethotrexate.
Knoll (Abbott) DE019
A phase III,multicenter,randomized,double-blind,placebo-controlledclinical use studytoevaluate the safetyand
tolerabilityof BMS-188667 administeredintravenouslytosubjectswithactive rheumatoidarthritiswithorwithoutco-
morbiditiesreceivingDMARDsand/orbiologicsapprovedforRA.
BMS IM101-031
A phase IIImulticenterstudyof the safetyandefficacyof the humananti-tnf monoclonal antibodyAdalimumab(D2E7)
insubjectswithmoderate toseverelyactive psoriaticarthritis.
AbbottM02-518
A multicentercontinuationtrial frompatientscompletingstudyM02-518 andM02-570 of the humananti-tnf
monoclonal antibodyadalimumab(D2E7) inpatientswithmoderate toseverelyactive psoriaticarthritis.
AbbottM02-537
A 4-weekrandomized,multicenter,double-blind,placeboandactive controlled,parallel-group,forced-titrationphaseIIB
studycomparingefficacyandsafetyof ascendingdosesof CG5503 prolongedrelease upto233 mg BID and oxycodone
prolongedrelease upto20 mg BID to placeboinsubjectswithmoderate toseverechronicpaindue toosteoarthritisof
the knee.
JohnsonandJohnsonR331333-PAI-2001
A phase 2A, randomized,double-blind,placebo-controlled,multicenterstudytocompare 3 dose levelsof CP-690-550vs.
placeboadministeredorallyBIDfor6 weeksinthe treatmentof the signsandsymptomsof subjectswithactive
rheumatoidarthritis.
PfizerA3921019
A randomized,double-blind,placebo-controlled,6monthstudyevaluatingCP-690-550inpatientswithrheumatoid
arthritiswiththe optiontoroll overintoA3921024.
PfizerA3931025
An observationalstudyforsubjectswhoearlytermedfromA3921025.
PfizerA3921029
A 13 week,multicenter,randomized,double-blind,double-dummy,placebo-controlled,parallelgrouptrial of
lumiracoxib(COX189) 100 mg o.d.inpatientswithprimaryhiposteoarthritisusingcelecoxib(200mg o.d.) asa positive
control.
NovartisCCOX189A2367

5. 5
A double-blind,12weekstudytoevaluate the efficacy,safetyandtolerabilityof ACZ885withthree different dose
regimesinsubjectswithactive rheumatoidarthritis.
NovartisCACZ885A2201
A double-blindBicifedineversusstandardof care intreatmentof lowerbackpain.
DOV
A phase 3, pivotal,multicenter,double-blind,randomized,placebo-controlledmonotherapystudyof milnacipranfor
treatmentof fibromyalgia.
CypressBioscience,Inc,FMS-034
A 12-weekrheumatoidarthritisstudywithVX-509whichisa specificinhibitorof JAK3activity.
Vertex VX09-5-9-101
A randomized,double-blind,placebo-controlledstudyof the efficacyandsafetyforneremexane inthe treatmentof
patientswithosteoarthritisof the knee.
ForestLaboratoriesNER-MD-11
A 14 week,randomized,double-blind,placebo-controlledtrial of pregabalintwice dailyinpatientswithfibromyalgia.
PfizerA0081077
A 12 week,open-label,safetytrial of pregabalininpatientswithfibromyalgia.
PfizerA0081078
An 8 week,randomized,double-blind,placebo-controlled,multicenterstudyof [S,S]-Reboxetine(PNU-165442G)
administeredonce dailyinpatientswithfibromyalgia.
PfizerA6061034
A randomized,placebo-controlled,double-blind,parallel group,international studytoevaluate the safetyandefficacyof
rituximab(MabThera®/Tituxan®) incombinationwithMethotrexate,comparedtoMethotrexate monotherapyin
patientswithactive rheumatoidarthritis.
Genentech,Inc.WA17045B/ U2973g SERENE
A randomized,double-blind,parallelgroup,international studytoevaluate the safetyandefficacyof ocrelizumab
comparedto placeboinpatients withactive RA whohave aninadequate response toatleast1 anti-TNFatherapy.
GenentechW20495/ACT3986g SCRIPT
A phase III,randomized,double-blind,placebo-controlled,multicenterstudyof the retreatmentwithrituximabin
subjectswithrheumatoid arthritisreceivingbackgroundMethotrexate.
Genentech,Inc.U3384-A1 SUNRISE
A randomized,double-blind,placebo-controlled,parallel groupstudyof the safetyandreductionof signsandsymptoms
duringtreatmentwithMRA versusplacebo,incombinationwithtraditional DMARDtherapyinpatientswithmoderate
to severe active rheumatoidarthritisandaninadequate responsetocurrentDMARD therapy.
Hoffmann-LaRoche Inc.WA18063
Long-termextensionstudyof safetyduringtreatmentwithtocilizumab(MRA) inpatientscompletingtreatmentinMRA
core studies.
Hoffmann-LaRoche Inc.WA18696

6. 6
A phase III,randomized,multicenter,double-blind,Allopurinol-controlledstudyassessingthe efficacyof oral Febuxostat
insubjectswithgout.
TAP F-GT06-153
A randomized,double-blind,12-weekstudytoevaluate the efficacyof ThermoProfeninthe Treatmentof patientswith
mildtomoderate painassociatedwithosteoarthritisof the knee.
ZARS,Inc. ZMK-301
Double-blind,parallel-group,randomizedstudyof the efficacy andsafetyof continuoususe of celecoxibvs.the “usual
use”celecoxibinthe treatmentof subjectswithchronicosteoarthritisof the hiporknee whorequire ananti -
inflammatorymedicationforcontrol of theirpain.
PfizerA3191173
A randomized,double-blind,parallel-groupof cardiovascularsafetyinosteoarthritisorrheumatoidarthritispatients
withor at highriskfor cardiovasculardisease comparingCelecoxibwithNaproxenandIbuprofen.
PfizerA3191172
An adaptive,dose-ranging,multicenter, single-blind,double-dummy,active-controlledtrial todetermine the targetdose
of canakinumab(ACZ885) inthe treatmentof acute flaresingout patientswhoare refractoryor contraindicatedto
NSAIDsand/orcolchicines.
NovartisCACZ885H2255
A multicenter,randomized,double-blindcomparisonof 4dose regimensof PLA-695,naproxenandplacebo
administereddailyfor weeksinsubjectswithactive osteoarthritisof the knee.
Wyeth3175A1-202-WW
A randomized,double-blind,placebo-controlled,multipledose studytoevaluate the safety,tolerabilityandefficacyof
AMG 827 in subjectswithrheumatoidarthritis.
Amgen20090061
A phase IIIB,multicenterstudywitha12-weekdouble blind,placebo-controlled,randomizedperiodfollowedbyan
open-label extensionphase toevaluate the safetyandefficacyof certolizumabpegoladministeredtopatientswith
active rheumatoidarthritis.
UCB C87094
A long-term,randomized,double-blind,parallel-group,placebo-controlled,radiographicstudytoinvestigate the safety
and efficacyof orallyadministeredSD-6010 insubjectswithsymptomaticOA of the knee.
PfizerA6171016
A phase IIIB,multicenter,randomized,double-blind,double-dummystudytoevaluate the efficacyandsafetyof
Abataceptadministeredsubcutaneouslyandintravenouslyinsubjectswithrheumatoidarthritisreceivingbackground
MTX andexperiencinganinadequateresponse toMTX.
BMS IM-101-174
A randomized,parallel-group,double-blind,placebo-controlledstudytoevaluatethe clinical efficacyand safetyof BMS-
582949 givenorallytosubjectswithrheumatoidarthritishavinganinadequate responsetoMTX.
BMS IM-119-015

7. 7
A long-term,open-label follow upstudyof CP-690-550, a moderatelyselective Janus-Kinase-3inhibitor,fortreatmentof
RA.
PfizerA3921024
A Phase 3, multicenter,randomized,double-blind,placebo-controlled,parallel groupstudyof 2 dosingregimensof
FostamatinibDisodium(FosD)inrheumatoidarthritispatientswithinadequate response toaTNF-alphaantagonist.
AstraZenecaD4300C00003
A multicenter,randomized,double-blind,placebo-controlled,parallel-groupstudyof the effectof Fostamatinib100mg
twice dailyon24-hour ambulatorybloodpressure inpatientswithrheumatoidarthritis.
AstraZenecaD4300C00033
A phase 3, multicenter,randomized,double-blind,placebo-controlled,parallel groupstudyof 2 dosingregimensof
FostamatinibDisodium(FosD)inrheumatoidarthritispatientswithinadequate response toDMARDS.
AstraZenecaD4300C00002
A multicenter,double-blind, randomized,parallel-armstudytodeterminethe effectof MTX dose onclinical outcome
and ultrasonographicsignsinsubjectswithmoderatelytoseverelyactive RA treatedwithadalimumab.
AbbottM12-071
A placebo-controlledstudyof ataciceptgivensub-qinsubjectswithRA andinadequateresponse toTNF α antagonist
therapy.
Serono27298
A randomized,double-blind,placebo-controlled,multicenter,phase 2studyof ataciceptin anti-TNFα naïve patients
withmoderate tosevere active RA andan inadequate response toMTX.
Serono27905
A double-blind,parallelgroupstudytoevaluate the safetyandefficacyof ocrelizumabcomparedtoplaceboinpatients
withactive rheumatoidarthritiscontinuingMTXtreatment.
Roche WA 20495/ACT3985g Stage
A multicenter, randomized,double-blind,parallel groupstudyof the safety,disease remissionandpreventionof
structural jointdamage duringtreatmentwithtocilizumab(TCZ),asamonotherapyandincombinationwithMTXversus
MTX inpatientswithearly,moderateto severe RA.
HoffmanLa Roche WA19926
A multicenter,randomized,blinded,parallel-groupstudyof the reductionof signsandsymptomsduringmonotherapy
treatmentwithtocilizumab(Actemra) 8mg/kgIV versusadalimumab(Humira) 40mg subcutaneousinpatientswith
rheumatoidarthritis.
HoffmanLa Roche WA19924
A phase 3, multicenter,randomized,double-blind,placebo-controlled,parallel-group,efficacyandsafetystudyof 2
dosesof apremilast(CC-10004) in subjectswithactive psoriaticarthritis.
Celgene CC-10004-PSA-003
A multicenter,randomized,double-blind,parallel-groupstudyof the reductionof signsandsymptomsduringtreatment
withactemraversushumiraincombinationwithMTXin patientswithmoderate tosevereactive rheumatoidarthritis
and an inadequate efficacyresponse totreatmentwithonlyone TNFinhibitor.
HoffmanLa Roche MA25522

8. 8
A multicenter,randomized,active-control,phase 3Bstudyto evaluate the cardiovascularsafetyof febuxostat(Uloric)
and allopurinolinsubjectswithgout andcardiovascularco-morbidities.
TakedaTMX-67-301
A randomized,double-blind,placebo-controlled,multicenter,two-part,doserangingandconfirmatorystudywithan
operationallyseamlessdesign,evaluatingefficacyandsafetyforSAR153191 ontop of MTX in patientswithactive
rheumatoidarthritiswhoare inadequateresponderstoMTXtherapy.
Sanofi-AventisEFC11072
A randomized,double-blind,placebo-controlled,doserangingstudywithanactive comparatorto evaluate the efficacy
and safetyof CDP6038 administeredsubcutaneouslyfor12 weekstosubjectswithactive rheumatoidarthritishaving
previouslyfailedTNFtherapy.
UCB RA0056
A phase 2, multicenter,open-label,followupstudytoassessthe long-termsafetyandefficacyof CDP6038 administered
subcutaneouslytosubjectswithactive rheumatoidarthritiswhocompletedstudyRA0056.
UCB RA 0057
A phase 2, double-blind,randomized,placebo-controlled,proof of concept,dose findingstudyof intra-articularbone
morphogeneticprotein(BMP-7) insubjectswithosteoarthritisof the knee.
StrykerBioscience 09-OA-002
A phase 3, multicenter,randomized,double-blind,placebo-controlledstudytoevaluatethe efficacyandsafetyof
subcutaneousLY2127399 in patientswithsystemiclupuserythematosus.
Eli LillyH9B-MC-BCDS
A randomized,double-blind,dose-response studyof the safetyandefficacyof oral BCX4208 addedto allopurinolin
subjectswithgoutwhohave notadequatelyrespondedtoallopurinolmonotherapy.
BioCrystBCX4208-203
A phase 1, randomized,placebo-controlled,two-period,fixedsequence studytoevaluate the effectof CP-690,550 on
measuredglomerularfiltrationrate inpatientswithactive rheumatoidarthritis.
PfizerA3921152
A double-blind,randomized,placebo-controlled,multicenter,dose-rangingstudytoevaluate the efficacyandsafetyof
PF-04236921 insubjectswithSLE.
PfizerLupusB0151006
A long-termextensionstudytoassessthe safetyandefficacyof fostamatinibdisodiuminthe treatmentof rheumatoid
arthritis.
AstraZenecaD4300C00005 OSKIRA X
A phase 3, double-blind,randomized,placebo-controlled,safetyandefficacystudyof once dailycontrolledrelease
pregabalininthe treatmentof patientswithfibromyalgia.
PfizerA0081245
A multicenter,uncontrolledextension studyevaluatingefficacyandsafetyof SAR153191 on topof DMARDs inpatients
withactive rheumatoidarthritis.
Sanofi-AventisLTS11201

9. 9
A phase 3b, multicenter,open-labelstudytoevaluate the long-termsafetyandefficacyof SQLY2127399 in patientswith
SLE.
Eli LillyH9B-MC-BCDX
A phase 1b, randomized,double-blind,placebo-controlledmultiple dosestudytoassessthe safety,tolerability,
pharmacokineticsandpharmacodynamicsof BIIB037 insubjectswithProdromal orMildAlzheimer’sDisease.
BiogenIdec221AD103
A phase 2 placebo-controlled,double-blind,parallel-group,Bayesianadaptive randomizationdesignanddose regimen
findingstudytoevaluate the safety,tolerabilityandefficacyof BAN2401 insubjectswithearlyAlzheimer’sDisease.
Eisai BAN2401-G000-201
Continuedefficacyandsafetymonitoringof Solanezumab,onAnti-AmyloidBAntibodyinpatientswithAlzheimer’s
Disease.
Eli LillyH8A-MC-LZAO
A phase 3 studyon effectof passive immunizationonthe progressionof mildAlzheimer’sDisease:LY2062430 vs
Placebo.
Eli LillyH8A-MC-LZAX
A phase 2 randomized,double-blind,placebo-controlled,parallel-group,multicenterstudytoevaluate the impact
MAB5102A onbrain amyloidloadandrelatedbiomarkersinpatientswithmildtomoderate Alzheimer’sDisease.
GenentechABE4955g
A phase 2, 24-month,multi-center,randomized,double-blind,placebo-controlled,parallel-group,amyloid-imaging
positronemissiontomography(PET) andsafetystudyof ACC-001and QS-21 adjuvantinsubjectswithmildto moderate
Alzheimer’sDisease.
JanssenACC-001-ALZ-2001
A phase 3 multicenter,double-blind,prospective,randomized,placebocontrolledstudyassessingthe efficacyandsafety
of Dysportusedforthe treatmentof lowerlimbspasticityinadultsubjectswithhemiparesisdue tostroke ortraumatic
braininjury.
IpsenY-55-52120-140
An open-label,randomizedstudyassessingthe efficacyandsafetyof Dysportusedforthe treatmentof lowerlimb
spasticityinadultsubjectswithhemiparesisdue tostroke or traumaticbraininjury.
IpsenY-55-52120-142
ALTernate approachesforclinical stage IIor IIIEstrogenReceptorpositive breastcancerNeoAdjuvantTrEatment
(ALTERNATE) inpostmenopausalwomen:A Phase IIIStudy.
ALLIANCEA011106
A randomized,phase III trial comparingaxillarylymphnode dissectiontoaxillaryradiationinbreastcancerpatients(cT1-
3 N1) who have positive sentinellymphnode diseaseafterneoadjuvantchemotherapy.
ALLIANCEA011202
Phase IIItrial of Enzlutamide (NSC#766085) versusEnzalutamide,Abiraterone andPrednisoneforcastrate resistant
metastaticprostate cancer.
ALLIANCEA031201

10. 10
A randomizedphase IIIstudyof Bendamustine plusRituximabversusIbrutinibplusRituximabversusIbrutinibalone in
untreatedolderpatients( >65 yearsof age) withChronicLymphocyticLeukemia(CLL).
A041202
A phase II/IIIrandomizedtrial of VelipariborplaceboincombinationwithadjuvantTemozolomide in newlydiagnosed
glioblastomawith MGMT PromoterHypermethylation.
ALLIANCEA071102
Randomizeddoubleblindplacebocontrolledstudyof Erlotiniborplaceboinpatientswithcompletelyresected
epidermal growthfactorreceptor(EGFR) mutantnon-small cell lungcancer(NSCLC).
ALLIANCEA081105
AdjuvantLungCancerEnrichmentMarker IdentificationandSequencingTrial (ALCHEMIST).
ALLIANCEA151216
A Phase IIIrandomizedtrial of LobectomyversusSublobarResectionforsmall (<2 CM) peripheral non-smallcell lung
cancer (NSCLC).
CALGB 140503
A phase IIItrial of 6 versus12 treatmentsof adjuvantFOLFOXplusCelecoxiborplaceboforpatientswithresectedStage
IIIcoloncancer.
CALGB/SWOG80702
A Phase IIIrandomizedstudyof SorafenibplusDoxorubicinversusSorafenibinpatientswithadvancedhepatocellular
carcinoma(HCC).
CALGB 80802
A RandomizedPhase IIIStudyof Ibrutinib(PCI-32765)-basedTherapyvsStandardFludarabine,Cyclophosphamide,and
Rituximab(FCR) ChemoimmunotherapyinUntreatedYoungerPatientswithChronicLymphocyticLeukemia(CLL.)
E1912
RandomizedPhase IIITrial of Bortezomib,LENalidomideandDexamethasone(VRd)VersusCarfilzomib,Lenalidomide
and Dexamethasone (CRd) FollowedbyLimitedorIndefinite DURationLenalidomide MaintenANCEinPatientswith
NewlyDiagnosedSymptomaticMultiple Myeloma(ENDURANCE).
E1A11
A RandomizedPhase IIITrial of Endocrine TherapyplusEntinostat/PlaceboinMenandPostmenopausal Womenwith
Hormone Receptor-PositiveAdvancedBreastCancer.
E2112
RandomizedPhase IIITrial Comparingthe Frequencyof MajorErythroid Response (MER) toTreatmentwith
Lenalidomide (Revlimid®) Alone andinCombinationwithEpoetinAlfa(Procrit®) inSubjectswithLow- orIntermediate-1
RiskMDS andSymptomaticAnemia.
E2905
RandomizedPhase IIITrial of LenalidomideVersusObservationAlone inPatientswithAsymptomaticHigh-Risk
SmolderingMultiple Myeloma.
E3A06

11. 11
A Phase IIIDouble-BlindTrial forSurgicallyResectedEarlyStage Non-Small CellLungCancer:CrizotinibversusPlacebo
for PatientswithTumorsHarboringthe Anaplastic LymphomaKinase (ALK)FusionProtein.
E4512
RandomizedPhase IIIStudyof Maintenance TherapywithBevacizumab,Pemetrexed,oraCombinationof Bevacizumab
and PemetrexedFollowingCarboplatin,Paclitaxel andBevacizumabforAdvancedNon-SquamousNSCLC.
E5508
A Phase IIIrandomizedcontrolledclinical trial of CarboplatinandPaclitaxel (orGemcitabine) alone orincomibination
withBevacizumab (NSC#704865, IND #113912) followedbyBevacizumabandsecondarycytoreductive surgeryin
platinum-sensitive,recurrentovarian,peritonealprimaryandfallopiantube cancer.
PROTOCOLGOG-0213
A Phase II/IIITrial of NeoadjuvantFOLFOXwithSelectiveUse of CombinedModalityChemoradiation
versusPreoperative CombinedModalityChemoradiationforLocallyAdvancedRectal CancerPatients
UndergoingLowAnteriorResectionwithTotal Mesorectal Excision(PROSPECT).
ALLIANCEN1048
Pre-operative assessmentandpost-operative outcomesof elderlywomenwithgynecological cancers.
NRG-CC002
A randomizedphase IItrial forpatientswithp16positive,non-smokingassociated,locoregionallyadvanced
oropharyngeal cancer.
NRG-HN002
A RandomizedPhase IIIClinical Trial Evaluating Post-MastectomyChestwall andRegionalNodal XRTandPost-
LumpectomyRegional NodalXRTinPatientswithPositive AxillaryNodesBefore NeoadjuvantChemotherapyWho
Convertto PathologicallyNegative AxillaryNodesAfterNeoadjuvantChemotherapy.
NSABPPROTOCOLB-51/RTOG PROTOCOL1304
A phase II-Rand a phase IIItrial evaluatingbothErlotinib(PHII-R) andChemoradiation(PHIII) asadjuvanttreatments
for patientswithresectedheadof pancreasadenocarcinoma.
RTOG 0848
A phase IIIstudyof postoperative radiationtherapy(IMRT) +/- Cetuximabforlocallyadvancedresectedheadandneck
cancer.
RTOG 0920
A phase IIItrial evaluatingthe additionof TrastuzumabtoTrimodalitytreatmentof HER2-overexpressingesophageal
adenocarcinoma.
RTOG 1010
EVEREST: EVErolimusforRenal CancerEnsuingSurgical Therapy,A Phase IIIStudy.
S0931
A Phase III,RandomizedClinicalTrial of StandardAdjuvant Endocrine Therapy+/- ChemotherapyinPatientswith1-3
Positive Nodes, Hormone Receptor-PositiveandHER2-Negative BreastCancerwith Recurrence Score (RS) of 25 or Less.
RxPONDER:A Clinical Trial Rx forPositive Node,Endocrine Responsive BreastCancer.
S1007

12. 12
Phase IIIrandomizedplacebo-controlledclinical trial evaluatingthe use of adjuvantendocrinetherapy+/- one yearof
Everolimusinpatientswithhigh-riskhormone receptor-positive andHER2/negative breastcancer.
BreastCancer Study – evaluatingEverolimuswithEndocrinetherapy.
S1207
A randomizedphase IIItrial of IntermittentversusContinuous dosingof Dabrafenib(NSC-763760) in BRAFV600E/K
mutantmelanoma.
S1320
Phase II/IIIBiomarker-Drivenmasterprotocol forsecondline therapyof squamouscell lungcancer(ScreeningStep).
S1400
Phase II/IIIrandomizedstudyof MED14736 versusDocetaxel assecondline therapyforpatientswithStage IV squamous
cell lungcancerand no matchingbiomarkers.
S1400A: (Non-Matchsub-study):Anti-PD-L1–MEDI4736 versusDocetaxel
A phase II/IIIrandomizedstudyof GDC-0032 versusDocetaxel assecondline therapyforPI3Kpositive patientswith
Stage IV squamouscell lungcancer.
S1400B: PI3K – GDC-0032 versusDocetaxel
A phase II/IIIrandomizedstudyof PalbociclibversusDocetaxelassecondline therapyforcell cycle gene alteration
positive patientswith Stage IV squamouscelllungcancer.
S1400C: CDK4/6 – PalbociclibversusDocetaxel
A phase II/IIIrandomizedstudyof AZD4547 versusDocetaxel assecondline therapyforFGFR-positivepatientswith
Stage IV squamouscell lungcancer.
S1400D: FGFR – AZD4547 versusDocetaxel
A RandomizedPhase IIIPost-OperativeTrial of PlatinumBasedChemotherapyVsObservationinPatientswithResidual
Triple-Negative Basal-LikeBreastCancerfollowingNeoadjuvantChemotherapy
EA1131
Thisphase II trial studieshowwell breast-conservingsurgeryandradiationtherapyworkintreatingpatientswith
multiple ipsilateralbreastcancer.
Z11102
A Phase IIEvaluationof Nivolumab,aFullyHumanAntibodyAgainstPD-1,inthe Treatmentof PersistentorRecurrent
Cervical Cancer.
NRG-GY002
Phase IIIComparisonof ThoracicRadiotherapyRegimensinPatientswithLimitedSmall Cell CancerAlsoReceiving
CisplatinandEtoposide.
CALGB-30610
A Phase IIIRandomizedTrial ComparingAndrogenDeprivationTherapy+TAK-700 withAndrogenDeprivationTherapy+
Bicalutamide inPatientswithNewlyDiagnosedMetastaticHormone Sensitive Prostate Cancer.
S1216
MolecularAnalysisforTherapyChoice (MATCH)
EYA131