ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Pfizer
Study ID
NCT01360554
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dacomitinib (PF-00299804) — DRUG
    Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing
  • Active Comparator (erlotinib) — DRUG
    Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing
  • Placebo erlotinib — DRUG
    placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
  • Placebo PF00299804 — DRUG
    placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing

Study Details

This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients with advanced non-small cell lung cancer, previously treated with at least one prior regimen. Analyses of primary objective (Progression Free Survival) will be done in two co-primary populations as defined in the protocol.

Key Dates

Start date
Jun 16, 2011
Status verified
Apr 2017
Primary completion
Sep 30, 2013
Completion
Sep 14, 2015

Study Design

Enrollment
878 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Blinded active PF-00299804 + blinded placebo comparator (erlotinib)
  • Active Comparator: B
    Blinded active comparator (erlotinib) + blinded placebo PF-00299804

Primary Outcome Measure

Progression-Free Survival (PFS) Per Independent Radiologic Review. [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, participants were followed up until progressive disease regardless of start of subsequent cancer therapy. ]

Locations (107)

FacilityCityStateZIP
University of Alabama at BirminghamBirminghamAlabama35233
University of Alabama at BirminghamBirminghamAlabama35249
University of Alabama at BirminghamBirminghamAlabama35294
Northwest Alabama Cancer CenterFlorenceAlabama35630
University of South Alabama Medical CenterMobileAlabama36617
University of South Alabama Mitchell Cancer InstituteMobileAlabama36604
Northwest Alabama Cancer CenterMuscle ShoalsAlabama35661
Ironwood physicians P C dba Ironwood Cancer & Research CentersChandlerArizona85224
Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersChandlerArizona85224
Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersGilbertArizona85297
Desert Oncology Associates dba Ironwood Cancer and Research CentersMesaArizona85202
Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersMesaArizona85206
Highlands Oncology Group PAFayettevilleArkansas72703
Highlands Oncology Group, PARogersArkansas72758
Central Hematology Oncology Medical Group Inc.AlhambraCalifornia91801
UCLA Hematology Oncology-AlhambraAlhambraCalifornia91801
City of HopeDuarteCalifornia91010
St. Jude Heritage HealthcareFullertonCalifornia92835
Administrative Address: UCLA Hematology Oncology-Clinical Research Unit (CRU)Los AngelesCalifornia90095
Drug Management OnlyLos AngelesCalifornia90095-1772
Drug Managerrent Only:Los AngelesCalifornia90095-1772
Drug Shipment Address: Ronald Reagan UCLA Medical Center, Drug Information CenterLos AngelesCalifornia90095
Regulatory Management Only:Los AngelesCalifornia90095
Regulatory Management:Los AngelesCalifornia90095
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095
TORI Central AdministrationLos AngelesCalifornia90095
UCLA West Medical PharmacyLos AngelesCalifornia90095-1772
Westwood Bowyer Clinic, Peter Morton Medical BuildingLos AngelesCalifornia90095
Central Hematology Oncology Medical Group, Inc.PasadenaCalifornia91107
UCLA/Pasadena Healthcare Hematology-OncologyPasadenaCalifornia91105
Cancer Care Associates Medical Group Inc.Redondo BeachCalifornia90277
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454
UCLA Hematology Oncology-ParksideSanta MonicaCalifornia90404
UCLA Hematology Oncology-Santa MonicaSanta MonicaCalifornia90404
UCLA Santa Monica Medical Center & Orthopedic HospitalSanta MonicaCalifornia90404
City of Hope South Pasadena Cancer CenterSouth PasadenaCalifornia91030
UCLA/Santa Clarita Valley Cancer CenterValenciaCalifornia91355
UCLA Cancer CenterWestlake VillageCalifornia91361
Norwalk HospitalNorwalkConnecticut06856
Cancer Institute of FloridaOrlandoFlorida32804
Florida HospitalOrlandoFlorida32803
Hematology and Oncology Consultants, P.A.OrlandoFlorida32804
Investigational Drug Services, Florida HospitalOrlandoFlorida32804
Hematology Oncology Associates of the Treasure CoastPort Saint LucieFlorida34952
Emory ClinicAtlantaGeorgia30322
Emory University HospitalAtlantaGeorgia30322
Emory University Hospital MidtownAtlantaGeorgia30308
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Northwest Georgia Oncology Centers, P.C.AustellGeorgia30106
Northwest Georgia Oncology Centers, P.C.CarrolltonGeorgia30117
Northwest Georgia Oncology Centers, PCCartersvilleGeorgia30121
John B. Amos Cancer CenterColumbusGeorgia31904
Atlanta Cancer CareDecaturGeorgia30033
Georgia Cancer SpecialistsDecaturGeorgia30033
The Cancer Center at DeKalb MedicalDecaturGeorgia30033
Northwest Georgia Oncology Centers, P.C.DouglasvilleGeorgia30134
Suburban Hematology-Oncology Associates, P.C.DuluthGeorgia30096
Northeast Georgia Medical CenterGainesvilleGeorgia30501
Oncology Specialists of North Georgia, LLCGainesvilleGeorgia30501
The Longstreet Clinic Cancer CenterGainesvilleGeorgia30501
Suburban Hematology-Oncology Associates, P.C.LawrencevilleGeorgia30046
Northwest Georgia Oncology Centers, P.C.MariettaGeorgia30060
Suburban Hematology-Oncology Associates, P.C.SnellvilleGeorgia30078
Illinois Cancer SpecialistsArlington HeightsIllinois60005
Ingalls Memorial HospitalHarveyIllinois60426
Ingalls Memorial Hospital - In-Patient PharmacyHarveyIllinois60426
Monroe Medical AssociatesHarveyIllinois60426
Illinois Cancer SpecialistsNilesIllinois60714
Monroe Medical AssociatesTinley ParkIllinois60477
Deaconess Clinic DowntownEvansvilleIndiana47713
Monroe Medical AssociatesMunsterIndiana46321
Cedar Valley Medical Specialists, P.C.WaterlooIowa50701
Kentucky Cancer ClinicHazardKentucky41701-9466
Baptist Hospital EastLouisvilleKentucky40207
University Medical Center, IncLouisvilleKentucky40202
University Medical Center, Inc.LouisvilleKentucky40202
Karmanos Cancer InstituteDetroitMichigan48201
Karmanos Cancer Institute at Farmington HillsFarmington HillsMichigan48334
North Mississippi Hematology and Oncology Associates, Ltd.StarkvilleMississippi39759
North Mississippi Hematology and Oncology Associates, Ltd.,TupeloMississippi38801
Siteman Cancer Center-St. PetersCity of Saint PetersMissouri63376-1645
Siteman Cancer Center-West CountyCreve CoeurMissouri63141
Barnes Jewish HospitalSt LouisMissouri63110-1094
Washington University School of Medicine-IDS PharmacySt LouisMissouri63110
Dartmouth-Hitchcock Medical Center /Mary Hitchcock Memorial HospitalLebanonNew Hampshire03756
Oncology and Hematology Specialists, P.A.DenvilleNew Jersey07834
Stony Brook University-Cancer CenterStony BrookNew York11794-9447
Carolina Oncology Specialists PAHickoryNorth Carolina28602
Carolina Oncology Specialists PALenoirNorth Carolina28645
Mercy clinic oklahoma communities, Inc. - Mercy clinic oncology/Hematology - NormanNormanOklahoma73071
Mercy Hospital Oklahoma City - Oncology InfusionOklahoma CityOklahoma73120
Mercy Physicians of Oklahoma-Communities, Inc. - Mercy Clinic Oncology/Hematology - McAuleyOklahoma CityOklahoma73120-8347
Good Samaritan Hospital Samaritan Ambulatory Infusion ServicesCorvallisOregon97330
Samaritan Hematology & Oncology ConsultantsCorvallisOregon97330
Samaritan Pharmacy ServicesCorvallisOregon97330
Samaritan North Lincoln HospitalLincoln CityOregon97367
Samaritan Pacific Communities HospitalNewportOregon97365
Guthrie Clinic, LimitedSayrePennsylvania18840
Robert Packer HospitalSayrePennsylvania18840
Texas Oncology-Longview Cancer CenterLongviewTexas75601
Texas Oncology-TylerTylerTexas75702
Texas Oncology - WacoWacoTexas76712
Kadlec Clinic Hematology and OncologyKennewickWashington99336
Kadlec Medical CenterRichlandWashington99352
Outpatient Imaging CenterRichlandWashington99352
Seattle Cancer Care AllianceSeattleWashington98109
University of Washington Medical CenterSeattleWashington98195

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University of Alabama at Birmingham· Birmingham, ALNorthwest Alabama Cancer Center· Florence, ALUniversity of South Alabama Medical Center· Mobile, ALUniversity of South Alabama Mitchell Cancer Institute· Mobile, ALNorthwest Alabama Cancer Center· Muscle Shoals, ALIronwood physicians P C dba Ironwood Cancer & Research Centers· Chandler, AZ

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