An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

PHASE3CompletedINTERVENTIONAL
Enrollment

347

Participants

Timeline

Start Date

September 30, 2009

Primary Completion Date

March 31, 2012

Study Completion Date

January 31, 2016

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
DRUG

PF-02341066

PF-02341066, 250 mg BID will be administered orally on a continuous schedule

DRUG

Pemetrexed

Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle

DRUG

Docetaxel

Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

Trial Locations (264)

100

National Taiwan University Hospital, Department of Internal Medicine, Taipei

112

Taipei Veterans General Hospital, Chest Department, Taipei

704

National Cheng Kung University Hospital, Tainan City

1121

Orszagos Koranyi TBC és Pulmonologiai Intezet, VI. Bronchologia, Budapest

1125

Semmelweis Egyetem Pulmonologia Intezet, Budapest

1527

"UMBAL Tsaritsa Yoanna - ISUL, Klinika po onkoterapiya", Sofia

1606

MBAL Voennomeditsinska Academia, MMA HAT Sofia, Sofia

1756

Spetsializirana Bolnitsa za Aktivno Lechenie po Onkologiya, Klinika po himioterapiya, Sofia

2045

Pest Megyei Tudogyogyintezet, III. Osztaly, Törökbálint

2050

Sydney Cancer Centre, Camperdown

3002

Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology, East Melbourne

4004

MDOZS Plovdiv EOOD; Parvo vatreshno himioterapevtichno otdelenie, Plovdiv

4032

Debreceni Egyetem Orvos- és Egészségtudományi Centrum, Tudogyogyaszati Klinika, Debrecen

5000

Royal Adelaide Hospital, Department of Medical Oncology, Adelaide

6009

Department of Medical Oncology, Nedlands

8000

Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly, Székesfehérvár

8582

Veszprem Megyei Onkormanyzat Tudogyogyintezete, Farkasgyepű

9002

"MDOZS Dr. Marko Markov, Otdelenie po onkoterapiya i paliativni grizhi", Varna

10022

Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion, New York

10032

Columbia University Medical Center, New York

10043

Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano (TO)

10065

Memorial Sloan-Kettering Cancer Center, New York

10126

Centro C.O.E.S., A.O. San Giovanni Battista Le Molinette, Torino

11042

NSLIJ Health System/Monter Cancer Center, Lake Success

11527

"General Hospital of Chest Diseases of Athens Sotiria", Athens

13126

Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians, Oswego

13210

Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians, Syracuse

13421

Department of Medicine MSG at SUNY HSC at Syracuse, INC., d/b/a University Physicians, Oneida

13915

Pr Fabrice BARLESI, Marseille

14076

Centre Francois Baclesse, Caen

15006

Complexo Hospitalario Universitario A Coruña. Hospital Teresa Herrera (Materno-Infantil), A Coruña

15232

University of Pittsburgh Medical Center-Shadyside, Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh

16132

Oncologia Medica A, Genova

19104

Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine, Philadelphia

Penn Presbyterian Medical Center, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20052

Nuovo Ospedale San Gerardo, Monza

20132

Dipartimento Oncologia Medica, UO Medicina 1Q A, Unita' Nuovi Farmaci e Terapie Innovative, Milan

20141

Istituto Europeo di Oncologia IRCCS, Milan

20162

Ospedale Niguarda Ca' Granda Dipartimento Oncologico, SC Divisione di Oncologia Medica Falk, Milan

21079

Centre Georges-François Leclerc, Dijon

21231

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

22527

MVZ Prof. Mathey, Pfrof. Schofer GmbH, Hamburg

22927

Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie, Großhansdorf

26121

Pius-Hospital Oldenburg, Oldenburg

27514

Investigational Drug Service, Pharmacy Department, UNC Hospitals, Chapel Hill

UNC Health Care, NC Cancer Hospital Infusion/lnpatient Pharmacy (CHIP), Chapel Hill

28046

Hospital Universitario La Paz, Madrid

30033

Georgia Cancer Specialists - Stemmer, Decatur

30060

Georgia Cancer Specialists-Kennestone, Marietta

30308

Emory University Hospital Midtown, Atlanta

30322

Emory Clinic, Atlanta

Emory University Clinic, Atlanta

Emory University Hospital, Atlanta

Winship Cancer Institution, Atlanta

30341

Georgia Cancer Specialists-Administrative Annex, Atlanta

30342

Georgia Cancer Specialists, Sandy Springs

31008

Hospital de Navarra, Pamplona

31217

Georgia Cancer Specialists-Macon, Macon

33006

Hospital Universitario Central de Asturias, Oviedo

33021

Memorial Cancer Institute, Hollywood

33028

Memorial Cancer Institute (West), Pembroke Pines

33461

Cancer Center of South Florida Foundation, Inc., Lake Worth

33612

H Lee Moffitt Cancer Center & Research Institute, Tampa

37055

Tennessee Oncology, PLLC, Dickson

37066

Tennessee Oncology, PLLC, Gallatin

37067

Tennessee Oncology, PLLC, Franklin

37076

Tennessee Oncology, PLLC, Hermitage

37087

Tennessee Oncology, PLLC, Lebanon

37130

Tennessee Oncology, PLLC, Murfreesboro

37167

Tennessee Oncology, PLLC, Smyrna

37203

Sarah Cannon Research Institute, Nashville

Tennessee Oncology, PLLC, Nashville

37205

Tennessee Oncology, PLLC, Nashville

37207

Tennessee Oncology, PLLC, Nashville

37211

Tennessee Oncology, PLLC, Nashville

38043

Hopital Albert Michallon, Grenoble

39008

Hospital Universitario Marques de Valdecilla, Santander

41013

Hospital Universitario Virgen Del Rocio, Seville

43205

The Ohio State University Hospital East, Columbus

43210

The Ohio State University James Cancer Hospital and Solove Research Institute, Columbus

43221

James Care in Kenny, Columbus

44195

Cleveland Clinic, Cleveland

44805

Centre Rene Gauducheau / Service d'Oncologie Medicale, Saint-Herblain

45122

Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung, Essen

46202

Indiana University Hospital, Indianapolis

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

Ship Drug to: Investigational Drug Services, Indianapolis

Wishard Memorial Hospital, Indianapolis

46290

Springmill Medical Clinic, Indianapolis

46321

Monroe Medical Associates, Munster

The Community Hospital, Munster

48201

Karmanos Cancer Institute, Detroit

48334

Lawrence and Idell Weisberg Cancer Treatment Center, Farmington Hills

50134

Azienda Ospedaliero-Universitaria Careggi, Florence

50937

Klinikum der Universitaet zu Koeln, Klinik I fuer Innere Medizin, Cologne

55043

Ospedale Versilia, Oncologia Medica, Lido Di Camaiore (LU)

55100

Ospedale San Luca, Lucca

57010

General Hospital of Thessaloniki Georgios Papanikolaou, Lung Cancer Neoplasia Research Department, Eksochi

60426

Ingalls Memorial Hospital (Drug Shipment Only), Harvey

Ingalls Memorial Hospital, Harvey

Monroe Medical Associates, Harvey

60477

Monroe Medical Associates, Tinley Park

60612

Rush University Medical Center, Chicago

60637

University of Chicago Medical Center, Chicago

63110

Washington University, School of Medicine, St Louis

63141

Siteman Cancer Center- West County, Creve Coeur

63376

Siteman Cancer Center, City of Saint Peters

65199

HSK Dr.- Horst-Schmidt-Kliniken, Innere Medizin III Haematologie, Onkologie, Palliativmedizin, Wiesbaden

69126

Thoraxklinik am Universitaetsklinikum Heidelberg, Internistische Onkologie der Thoraxtumoren, Heidelberg

71110

University General Hospital of Heraklion/ Department of Clinical Oncology, Heraklion

72205

University of Arkansas for Medical Research, Winthrop Rockefeller Cancer Institute, Little Rock

75679

Groupe Hospitalier Cochin, Paris

75970

Hopital Tenon / Service de Pneumologie, Paris

77030

The University of Texas, Houston

80026

Kaiser Permanente, Lafayette

80045

Drug Shipment: University of Colorado Cancer Center, Anschutz Cancer Pavilion, Aurora

University of Colorado Denver (CTRC), Aurora

Unviersity of Colorado Hospital, Anschutz Cancer Pavilion, Aurora

Unviersity of Colorado Hospital, Anschutz Inpatient Pavilion, Aurora

80205

Kaiser Permanente, Denver

80336

Klinikum der Universitaet Muenchen, Medizinische Klink - Innenstadt, Pneumologie, München

83100

A.O. di Rilievo Nazionale e di Alta Specialita - S. G. Moscati, Avellino

90095

Ronald Reagan UCLA Medical Center, Los Angeles

UCLA Hematology Oncology, Los Angeles

UCLA Ophthalmic Oncology Center, Los Angeles

University of California-Los Angeles, Los Angeles

90211

Tower Hematology Oncology Medical Group, Beverly Hills

90404

Santa Monica-UCLA Medical Center and Orthopaedic Hospital, Santa Monica

University of California, Los Angeles, Santa Monica

92037

UCSD Medical Center -La Jolla, La Jolla

92103

UCSD Medical Center- Hillcrest, San Diego

93309

Comprehensive Blood and Cancer Center, Bakersfield

94305

Stanford University-Cancer Center, Palo Alto

94805

Institut Gustave Roussy, Villejuif

95403

Redwood Regional Medical Group, Inc., Santa Rosa

95817

UC Davis Cancer Center, Sacramento

University of California Davis Medical Center, Sacramento

96813

Cancer Research Center of Hawaii, Honolulu

Hawaii Medical Center East, Honolulu

OnCare Hawaii, Inc., Honolulu

97239

Oregon Health and Science University, Portland

98104

Swedish Cancer Institute, Seattle

98109

Seattle Cancer Care Alliance, Seattle

98122

Investigational Drug Service, Seattle

Swedish Medical Center, Seattle

98195

University of Washington Medical Center, Seattle

100021

Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Beijing

100071

307 Hospital of PLA, Beijing

115478

"State Institution National Cancer Research Center named after N.N. Blokhin' RAMS", Moscow

197022

City Clinical Oncology Dispensary, Saint Petersburg

Saint-Petersburg State Medical University named after I.P.Pavlov of Roszdrav, Saint Petersburg

197089

Research Institute of Pulmonology, Saint-Peterburg

198255

City Clinical Oncology Dispensary, Saint Petersburg

200030

Shanghai Chest Hospital/Department of Pulmonary Medicine, Shanghai

Shanghai Chest Hospital, Shanghai

200032

Zhongshan Hospital Fudan University / Respiratory Department, Shanghai

200433

Shanghai Pulmonary Hospital/Dept. of Oncology, Shanghai

210002

Nanjing Bayi Hospital, Nanjing

354057

"State Medical Institution Oncology Center #2 of Healthcare Department of Krasnodar Region", Sochi

420029

Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic, Kazan'

510060

SUN Yat-Sen University Cancer Center, Guangzhou

510080

Guangdong General Hospital, Guangzhou

90211-1850

Tower Cancer Research Foundation, Beverly Hills

92093-0698

Moores UC San Diego Cancer Center, La Jolla

90095-6984

Drug Shipping Address: [IRB# 10-001530] Ronald Reagan UCLA, Los Angeles

92868-3298

Ship Drug To : Kevin Kong- University of California, Irvine-Pharmacy, Orange

University of California, Irvine-Medical Center, Orange

06510

Drug Shipping for Yale; C/O Thomas Ferencz, RPh, BCOP, New Haven

Smilow Cancer Hospital at Yale New Haven, New Haven

06519

Clinical Trial Office, New Haven

06520

Yale Cancer Center, New Haven

02114

Massachusette General Hospital, Boston

Massachussetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

02215

Beth Isreal Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

DFCI/Pharmacy (Drug Shipment Only), Boston

63110-1094

Barnes-Jewish Hospital, St Louis

03756-0001

Dartmouth Hitchcock Medical Center, Lebanon

13210-2306

SUNY Upstate Medical University, Syracuse

27599-7600

UNC Hospitals, Chapel Hill

17033-0850

Penn State Milton S. Hershey Medical Center, Penn State Hershey Cancer Institute, Hershey

02914

Vincent Armenio, MD, East Providence

02915

Pharma Resource, East Providence

37203 (Pharmacy)

Sarah Cannon Research Institute, Nashville

37232-5536

The Vanderbilt Cancer Clinic, Nashville

37232-7610

The Vanderbilt Chemo Pharmacy, Nashville

40170-110

Nucleo de Oncologia da Bahia, Salvador

20231 -050

Instituto Nacional de Câncer - INCA, Rio de Janeiro

98700-000

Associacao Hospital de Caridade de Ijui, Ijuí

90050-170

Irmandade da Santa Casa de Misericordia de Porto Alegre, Porto Alegre

90610-000

Hospital Sao Lucas da PUCRS, Porto Alegre

14784-400

Fundacao Pio XII Hospital de Cancer de Barretos, Barretos

17210-120

Fundacao Hospital Amaral Carvalho, Jaú

01246-000

"Instituto do Câncer de São Paulo Octavio Frias de Oliveira - ICESP", São Paulo

01509-900

Fundacao Antonio Prudente, São Paulo

T2N 4N2

Tom Baker Cancer Centre, Calgary

T2S 3C3

Alberta Health Services, Holy Cross Site, Calgary

T2V 2C4

Office of Dr. John McWhae, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

E1C 2Z3

Dr. Georges-L. Dumont Regional Hospital, Moncton

E1C 8X3

Dr. Leon Richard Oncology Centre, Moncton

L1G 2B9

RSM Durham Regional Cancer Centre, Oshawa

L1J 8N8

Dr. Dana Blakolmer and Associates, Oshawa

K1H 8L6

The Ottawa Hospital Cancer Centre, Ottawa

H2L 4M1

Hopital Notre-Dame du Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal

H3A 1A1

Royal Victoria Hospital, Montreal

H3G 1A4

Montreal General Hospital, Montreal

H3T 1E2

Jewish General Hospital, Montreal

H3T 1M5

St. Mary's Hospital Center, Montreal

06189

Centre Antoine Lacassagne, Nice

01307

Universitaetsklinik Carl-Gustav-Carus Dresden, Dresden

Unknown

Tuen Mun Hospital, Department of Clinical Oncology, Tuenmen

Division of Respiratory and Critical Care Medicine, Department of Medicine, Queen Mary Hospital, Pokfulam

Department of Clinical Oncology, Prince of Wales Hospital, Shatin, New Territories

Aseptic Compounding Unit, Dublin

Department of Medical Oncology, Dublin

Department of Medical Oncology, Galway

Merlin Park Imaging Centre, Galway

Pharmacy Aseptic Service Unit, Galway

06132

SC Oncologia Medica, Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia, Perugia

00152

Unita' Operativa Complessa di Pneumologia Oncologica I, Padiglione Flaiani, Roma

464-8681

Aichi cancer center central hospital, Nagoya

277-8577

National Cancer Center Hospital East, Kashiwa

811-1395

National Kyushu Cancer Center, Fukuoka

003-0804

National Hospital Organization Hokkaido Cancer Center, Sapporo

673-8558

Hyogo Cancer Center, Akashi

700-8558

Okayama University Hospital, Okayama

589-8511

Kinki University Hospital, Osakasayama-shi

411-8777

Shizuoka Cancer Center, Sunto-gun

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

The Cancer Institute Hospital of JFCR, Tokyo

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

10-344

Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany, Olsztyn

10-357

Centrum Medyczne Ars Medica, Olsztyn

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Olsztyn

10-561

Wojewodzki Szpital Specjalistyczny w Olsztynie, Olsztyn

05-400

"Pracownia Tomografii Komputerowej ALL MEDI Sp. z o.o.", Otwock

Centralna Izba Przyjec Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy, Otwock

80-952

Klinika Onkologii i Radioterapii, Gdansk

Uniwersyteckie Centrum Kliniczne, Gdansk

60-569

Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii, Poznan

Zaklad Diagnostyki Obrazowej, Poznan

02-676

Lux Med. Sp.z o.o, Warsaw

410-769

National Cancer Center, Center for Lung Cancer, Goyang-si

110-744

Seoul National University Hospital / Department of Internal Medicine, Seoul

135-710

Samsung MedicaCenter,SungkyunkwanUnivSchoolofMedicine,Div. of Hematology-Oncology, Dep. of Medicine, Seoul

08916

Hospital Universitari Germans Trias I Pujol, Badalona

08003

Hospital Del Mar, Barcelona

08035

Hospital General Universitari Vall D´Hebron, Barcelona

08907

Institut Catala Doncologia - Hospital Duran I Reynals, L'Hospitalet de Llobregat

08208

Consorcio Hospitalario Parc Tauli, Sabadell

171 76

Karolinska Universitetssjukhuset, Onkologiska kliniken, Stockholm

SM2 5PT

Royal Marsden Hospital, Sutton

SK8 2PX

The Alexandra Hospital, Cheshire

SO53 2DW

Nuffield Health Wessex Hospital, Eastleigh

NW3 2QG

Royal Free Hospital, London

SE1 9RT

Kings College London at Guy's Hospital, London

SW3 6JJ

Royal Marsden Hospital, London

M20 4BX

Christie Hospital NHS Trust, Department of Medical Oncology, Manchester

OX3 7LJ

Cancer and Haematology Centre,, Oxford

SO16 6YD

Southampton University Hospitals NHS Trust, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT00932893 - An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene | Biotech Hunter | Biotech Hunter