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

First listed
May 25, 2011
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)

FacilityCityStateZIPSite coordinators
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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