AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 2NCT00932451

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

A Phase 2 study testing PF-02341066 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 280 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
PF-02341066
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,069 participants
Where
280 sitesin 22 countries
Study dates
Jan 2010to Dec 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  • may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  • Tumors can be measurable or non measurable

Who cannot join

  • prior treatment with PF-02341066
  • received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  • current enrollment in another therapeutic clinical trial

Trial locations and contacts

280 sites in 22 countries.

280 sites in 22 countries

United States140 sites

  • University of New Mexico Eye Clinic

    Albuquerque, New Mexico, 87106

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory Clinic

    Atlanta, Georgia, 30322

  • Emory University Clinic

    Atlanta, Georgia, 30322

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Winship Cancer Institution

    Atlanta, Georgia, 30322

  • Georgia Cancer Specialists - Administrative Annex

    Atlanta, Georgia, 30341

  • MCG Health Cancer Center Pharmacy

    Augusta, Georgia, 30912

  • MCG Health System Pharmacy (Drug Shipment Only)

    Augusta, Georgia, 30912

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • DRUG SHIPMENT: University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • Rocky Mountain Lions Eye Institute

    Aurora, Colorado, 80045

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21231

  • The Harry and Jeanette Cancer Research Building

    Baltimore, Maryland, 21231

  • National Institutes of Health National Cancer Institute

    Bethesda, Maryland, 20892

  • Tower Cancer Research Foundation

    Beverly Hills, California, 90211-1850

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211-1850

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusette General Hospital

    Boston, Massachusetts, 02114

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Isreal Deaconess Medical Center, Pharmacy FD B18

    Boston, Massachusetts, 02115

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute/Pharmacy

    Boston, Massachusetts, 02215

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • UNC Health Care

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7600

  • Medical University of South Carolina - Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Presbyterian Hospital Cancer Center

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center (Attn: J Pi PharmD / A. Patel Pharm D)

    Chicago, Illinois, 60637

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Hospital East

    Columbus, Ohio, 43205

  • The Ohio State University Investigational Drug Services

    Columbus, Ohio, 43210

  • The Ohio State University James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • James Care in Kenny

    Columbus, Ohio, 43221

  • UT Southwestern Medical Center - Simmons Cancer Center Pharmacy

    Dallas, Texas, 75390-9015

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • University of Texas Southwestern University Hospital - Zale Lipshy

    Dallas, Texas, 75390

  • UT Southwestern University Hospital - William P. Clements, Jr

    Dallas, Texas, 75390

  • Georgia Cancer Specialists-Stemmer

    Decatur, Georgia, 30033

  • Kaiser Permanente Colorado - Franklin

    Denver, Colorado, 80205

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • Vincent Armenio, MD

    East Providence, Rhode Island, 02914

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • Karmanos Cancer lnstitute at Farmington Hllls

    Farmington Hills, Michigan, 48334

  • Michael and Dianne Bienes Cancer Center, Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Ingalls Memorial Hospital (Drug Shipment Only)

    Harvey, Illinois, 60426

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Monroe Medical Associates

    Harvey, Illinois, 60426

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

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

    Hershey, Pennsylvania, 17033-0850

  • Memorial Cancer Institute

    Hollywood, Florida, 33021

  • OnCare Hawaii, Inc.

    Honolulu, Hawaii, 96813

  • University of Hawaii - Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Hawaii Medical Center East

    Honolulu, Hawaii, 96817

  • The University of Texas

    Houston, Texas, 77030

  • Presbyterian Hospital Huntersville

    Huntersville, North Carolina, 28078

  • Southern Oncology Specialists

    Huntersville, North Carolina, 28078

  • Indiana University Hospital Clarian Health

    Indianapolis, Indiana, 46202

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Ship drug to: Investigational Drug Services

    Indianapolis, Indiana, 46202

  • Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Springmill Medical Clinic

    Indianopolis, Indiana, 46290

  • Moores UCSD Cancer Center

    La Jolla, California, 92037

  • UCSD Medical Center - La Jolla

    La Jolla, California, 92093-0698

  • Kaiser Permanente Colorado - Rock Creek

    Lafayette, Colorado, 80026

  • NSLIJ Health System/Monter Cancer Center

    Lake Success, New York, 11042

  • Cancer Center of South Florida Foundation, Inc.

    Lake Worth, Florida, 33461

  • Dartmouth Hitchcock Medical Center/Mary Hitchcock Memorial Hospital

    Lebanon, New Hampshire, 03756-0001

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Drug Shipping Address: Ronald Reagen University of California-Los Angeles

    Los Angeles, California, 90095-6984

  • Ronald Reagen University of California-Los Angeles Medical Center

    Los Angeles, California, 90095

  • UCLA Opthalmic Oncology Center

    Los Angeles, California, 90095

  • University of California-Los Angeles

    Los Angeles, California, 90095

  • Georgia Cancer Specialists-Macon

    Macon, Georgia, 31217

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Georgia Cancer Specialists-Kennestone

    Marietta, Georgia, 30060

  • Presbyterian Hospital Matthews

    Matthews, North Carolina, 28105

  • Monroe Medical Associates

    Munster, Indiana, 46321

  • The Community Hospital

    Munster, Indiana, 46321

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37130

  • Sarah Cannon Research Institute (Administration)

    Nashville, Tennessee, 37203

  • Sarah Cannon Research Institute (Pharmacy)

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt Cancer Clinic

    Nashville, Tennessee, 37232-5536

  • The Vanderbilt Chemo Clinic

    Nashville, Tennessee, 37232-7610

  • Smilow Cancer Center at Yale New Haven, Oncology Pharmacy

    New Haven, Connecticut, 06510

  • Smilow Cancer Hospital at Yale New Haven

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06520

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Memorial Sloan-Kettering Cancer Center: Rockefeller Outpatient Pavilion

    New York, New York, 10022

  • Columbia University Medical Center

    New York, New York, 10032

  • IP Shipment: CUMC Research Pharmacy

    New York, New York, 10032

  • Memorial Sloan - Kettering Cancer Center

    New York, New York, 10065

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

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

    Oneida, New York, 13421

  • University of California, Irvine-Medical Center

    Orange, California, 92868-3298

  • University of California, Irvine-Pharmacy

    Orange, California, 92868-3298

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

    Oswego, New York, 13126

  • Stanford University-Cancer Center

    Palo Alto, California, 94305

  • Memorial Cancer Center (West)

    Pembroke Pines, Florida, 33028

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • UCSD Medical Center - Hillcrest

    San Diego, California, 92103

  • Georgia Cancer Specialists-Northside

    Sandy Springs, Georgia, 30342

  • Santa Monica-UCLA Medical Center & Orthopaedic Hospital Clinical Laboratory

    Santa Monica, California, 90404

  • UCLA Hematology Oncology-Santa Monica

    Santa Monica, California, 90404

  • University of California-Los Angeles

    Santa Monica, California, 90404

  • Redwood Regional Medical Group Inc

    Santa Rosa, California, 95403

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Lisa Nakatsu, RPh (Drug Shipment Address)

    Seattle, Washington, 98122

  • Swedish Medical Center

    Seattle, Washington, 98122

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110-1094

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University, Regional Oncology Center

    Syracuse, New York, 13210-2306

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

    Syracuse, New York, 13210

  • H Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Monroe Medical Associates

    Tinley Park, Illinois, 60477

Other trials in United States

Canada14 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Alberta Health Services, Holy Cross Site

    Calgary, Alberta, T2S 3C3

  • Office of Dr. John McWhae

    Calgary, Alberta, T2V 2C4

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Dr. Georges-L. Dumont Regional Hospital

    Moncton, New Brunswick, E1C 2Z3

  • Dr. Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

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

    Montreal, Quebec, H2L 4M1

  • Royal Victoria Hospital

    Montreal, Quebec, H3A 1A1

  • Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • Jewish General Hospsital

    Montreal, Quebec, H3T 1E2

  • St. Mary's Hospital Center

    Montreal, Quebec, H3T 1M5

  • RSM Durham Regional Cancer Centre - Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9

  • Dr. Dana Blakolmer and Associates

    Oshawa, Ontario, L1J 8N8

  • The Ottawa Hospital Cancer Center

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Italy14 sites

  • Divisione di Oncologia Medica, Ospedale San Giuseppe Moscati, Citta' Ospedaliera

    Avellino, 83100

  • S.C. Oncologia Medica

    Florence, 50134

  • Oncologia Medica A

    Genova, 16132

  • Ospedale Versilia, Oncologia Medica

    Lido Di Camaiore (LU), 55043

  • Ospedale San Luca

    Lucca, 55100

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

    Milan, 20132

  • Farmacia Istituto Europeo di Oncologia

    Milan, 20141

  • Istituto Europeo di Oncologia

    Milan, 20141

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

    Milan, 20162

  • Nuovo Ospedale San Gerardo

    Monza, 20900

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano (TO), 10043

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

    Perugia, 06156

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

    Roma, 00152

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

    Torino, 10126

Other trials in Italy

Spain11 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, Galicia, 15006

  • Hospital Universitari Germans Trias I Pujol

    Badalona, Barcelona, 08916

  • Hospital Del Mar

    Barcelona, Barcelona, 08003

  • Hospital General Universitari Vall D´Hebron

    Barcelona, Barcelona, 08035

  • Institut Catala D'Oncologia - Hospital Duran I Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital de Navarra

    Pamplona, 31008

  • Consorcio Hospitalario Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

Other trials in Spain

Japan10 sites

  • Hyogo Cancer Center

    Akashi, Hyōgo, 673-8558

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045

  • National Kyushu Cancer Center/Department of Thoracic Oncology

    Fukuoka, 811-1395

  • National Cancer Center Hospital East

    Kashiwa, 277-8577

  • Aichi cancer center central hospital

    Nagoya, Aichi-ken, 464-8681

  • Okayama University Hospital

    Okayama, Okayama-ken, 700-8558

  • Kinki University Hospital

    Osakasayama-shi, Osaka, 589-8511

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

Other trials in Japan

Brazil9 sites

  • Fundacao Pio XII Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Associacao Hospital de Caridade de Ijui

    Ijuí, Rio Grande do Sul, 98700-000

  • Fundacao Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Sao Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional do Câncer - INCA

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Nucleo de Oncologia da Bahia

    Salvador, Estado de Bahia, 40170-110

  • Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira - ICESP

    São Paulo, São Paulo, 01246-000

  • Fundacao Antonio Prudente

    São Paulo, São Paulo, 01509-900

Other trials in Brazil

China9 sites

  • Cancer Institute and Hospital Chinese Academy of Medical Sciences and PUMC, Internal 4 Department

    Beijing, 100021

  • 307 Hospital of PLA

    Beijing, 100071

  • SUN Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong General Hospital

    Guangzhou, 510080

  • Nanjing Bayi Hospital

    Nanjing, Jiangsu, 210002

  • Shanghai Chest Hospital/Department of Pulmonary Medicine

    Shanghai, 200030

  • Shanghai Chest Hospital

    Shanghai, 200030

  • Zhongshan Hospital Fudan University / Respiratory Department

    Shanghai, 200032

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

Other trials in China

France9 sites

  • Centre Francois Baclesse

    Caen, 14076

  • Centre Georges-François Leclerc

    Dijon, 21079

  • Hopital Albert Michallon

    Grenoble, 38043

  • APHM - Hopital Nord / Service d'Oncologie Multidisciplinaire et Innovations Thérapeutiques

    Marseille, 13915

  • Centre Antoine Lacassagne

    Nice, 06189

  • Hospital Cochin

    Paris, 75014

  • Hopital Tenon

    Paris, 75970

  • Centre Rene Gauducheau / Service d'Oncologie Medicale

    Saint-Herblain, 44805

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany9 sites

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

    Cologne, 50937

  • Universitaetsklinikum Carl-Gustav-Carus Dresden

    Dresden, 01307

  • Westdeutsches Tumorzentrum, Universitaetsklinikum Essen, Innere Klinik - Tumorforschung

    Essen, 45122

  • Krankenhaus Grosshansdorf, Zentrum fuer Pneumologie und Thoraxchirurgie

    Großhansdorf, 22927

  • Ambulantes Krebszentrum Hamburg

    Hamburg, 22527

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

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

    München, 80336

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • HSK Dr.- Horst-Schmidt-Kliniken

    Wiesbaden, 65199

Other trials in Germany

Poland8 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Poland, 80-952

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Pracownia Optyczna Bozena Lawrynowicz Optyk Dyplomowany

    Olsztyn, Poland, 10-344

  • Ars Medica

    Olsztyn, Poland, 10-357

  • Wojewodzki Szpital Specjalistyczny w Olsztynie, Zaklad Medycyny Nuklearnej

    Olsztyn, Poland, 10-561

  • Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc

    Olsztyn, 10-357

  • Oddzial Onkologii Klinicznej z Pododdzialem Dziennej Chemioterapii

    Poznan, 60-569

  • Zaklad Diagnostyki Obrazowej

    Poznan, 60-569

Other trials in Poland

United Kingdom8 sites

  • Nuffield Health Wessex Hospital

    Eastleigh, SO53 2DW

  • Cancer and Haematology Centre,

    Headington, Oxford, OX3 7LJ

  • Department of Oncology

    London, NW3 2QG

  • Kings College London at Guy's Hospital

    London, SE1 9RT

  • Royal Marsden Hospital

    London, SW3 6JJ

  • Christie Hospital NHS Trust, Department of Medical Oncology

    Manchester, M20 4BX

  • Somers Cancer Research Building, M824

    Southampton, SO16 6YD

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Hungary6 sites

  • Orszagos Koranyi TBC es Pulmonologiai Intezet, VI. Bronchologia

    Budapest, 1121

  • Semmelweis Egyetem Pulmonologia Intezet

    Budapest, 1125

  • Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Tudogyogyaszati Klinika

    Debrecen, 4032

  • Veszprem Megyei Onkormanyzat Tudogyogyintezete

    Farkasgyepű, 8582

  • Fejer Megyei Szent Gyorgy Korhaz, Pulmonologiai Osztaly

    Székesfehérvár, 8000

  • Pest Megyei Tudogyogyintezet, III. Osztaly

    Törökbálint, 2045

Other trials in Hungary

Russia6 sites

  • Republican Clinical Oncology Dispensary of the Ministry of Health of Tatarstan Republic

    Kazan', 420029

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

    Moscow, 115478

  • City Clinical Oncology Dispensary

    Saint Petersburg, 197022

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

    Saint Petersburg, 197022

  • Research Institute of Pulmonology

    Saint Petersburg, 197089

  • City Clinical Oncology Dispensary

    Saint Petersburg, 198255

Other trials in Russia

Ireland5 sites

  • Aseptic Compounding Unit

    Dublin, Dublin, 8

  • Department of Medical Oncology

    Dublin, Dublin, Dublin 8

  • Department of Medical Oncology

    Galway, Ireland

  • Merlin Park Imaging Centre

    Galway, Ireland

  • Pharmacy Aseptic Services Unit

    Galway, Ireland

Other trials in Ireland

Australia4 sites

  • Royal Adelaide Hospital, Department of Medical Oncology

    Adelaide, South Australia, 5000

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Peter MacCallum Cancer Centre, Division of Haematology and Medical Oncology

    East Melbourne, Victoria, 3002

  • Department of Medical Oncology

    Nedlands, Western Australia, 6009

Other trials in Australia

Bulgaria4 sites

  • UMHAT Tsaritsa Yoanna - ISUL

    Sofia, Bulgaria, 1527

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

    Sofia, Bulgaria, 1756

  • MBAL Voennomeditsinska Academia, MMA HAT Sofia

    Sofia, 1606

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

    Varna, 9002

Other trials in Bulgaria

Greece3 sites

  • General Hospital of Chest Diseases of Athens "Sotiria"

    Athens, 11527

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

    Eksochi, Thessaloniki, 57010

  • University General Hospital of Heraklion/ Department of Clinical Oncology

    Heraklion, Crete, 71110

Other trials in Greece

Hong Kong3 sites

  • 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

  • Tuen Mun Hospital, Department of Clinical Oncology

    Tuen Mun, New Territories

Other trials in Hong Kong

South Korea3 sites

  • National Cancer Center, Center for Lung Cancer

    Gyeonggi-do, 410-769

  • Seoul National University Hospital / Department of Internal Medicine

    Seoul, 110-744

  • Samsung Medical Center, Sungkyunkwan Univ School of Medicine

    Seoul, 135-710

Other trials in South Korea

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital, Department of Internal Medicine

    Taipei, 100

  • Taipei Veterans General Hospital, Chest Department

    Taipei, 112

Other trials in Taiwan

Netherlands1 site

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

Other trials in Netherlands

Sweden1 site

  • Karolinska Universitetssjukhuset, Onkologiska kliniken

    Stockholm, 171 76

Other trials in Sweden

About this study

Official title: Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus

This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.

Being tested
PF-02341066
Keywords
Lung Neoplasms ALK gene Crizotinib
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-02341066Drug

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

Study groups in NCT00932451
Study groupRoleWhat they receive
PF-0231066ExperimentalNot described
Receives: Drug: PF-02341066

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate

    The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.

    Measured: 6 years

  2. Percentage of Participants With Adverse Events

    Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.0).

    Measured: 6 years

Secondary outcomes (15)

  1. Duration of Response (DR)

    DR was defined as the time from the first documentation of objective tumor response (CR or PR) that was subsequently confirmed, to the first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. DR (in months) was calculated as (first date of PD or death - first date of CR or PR that was subsequently confirmed + 1)/30.4.

    Measured: 6 years

  2. Time to Tumor Response (TTR)

    TTR was defined as the time (in weeks) from the date of Cycle 1 Day 1 dose to first documentation of objective tumor response (CR or PR) that was subsequently confirmed. For participants proceeding from PR to CR, the onset of PR was taken as the onset of response.

    Measured: 6 years

  3. Disease Control Rate (DCR)

    DCR at 6 and 12 weeks was defined as the percentage of participants with a confirmed CR, confirmed PR, or SD (according to RECIST v 1.1) at 6 weeks and 12 weeks, respectively.

    Measured: 6 years

  4. Progression Free Survival (PFS)

    PFS was defined as the time from the date of the Cycle 1 Day 1 dose to the date of the first documentation of objective tumor progression or death on study due to any cause, whichever occurred first.

    Measured: 6 years

  5. Overall Survival (OS)

    OS was defined as the time from the Cycle 1 Day 1 dose to the date of death due to any cause. OS (in months) was calculated as (date of death - date of Cycle 1 Day 1 dose + 1)/30.4.

    Measured: 6 years

  6. Probability of Survival

    Six-month and 1-year survival probabilities were defined as the probabilities of survival at 6 months and 1 year, respectively, after the date of the Cycle 1 Day 1 dose based on the Kaplan-Meier estimate.

    Measured: 6 years

  7. Plasma Concentrations of Crizotinib (PF-02341066) and Its Metabolite PF-06260182

    Plasma concentrations of crizotinib (PF-02341066) and its metabolite PF-06260182. The method of dispersion is % coefficient of variation.

    Measured: 6 years

  8. Molecular Profiling (ALK Status) Descriptive Statistics for ALK Percentage of Positive Cells by Central Laboratory Test (SA [ALK Positive by IUO] Population)

    Molecular profiling outcomes included:Types of EML4-ALK fusion variants and ALK protein expression; Although a secondary objective was defined to explore the relationship of ALK gene fusion to the presence of ALK protein and fusion transcript, no additional analyses of ALK fusion variants or ALK protein were performed for technical reasons. Analyses of change from Baseline in the expression of biomarkers relevant to signaling pathways were not performed because paired Baseline and on-treatment (Cycle 2) tumor tissue required for the analysis, which were to be collected on an optional basis, were not available.

    Measured: 6 years

  9. Genotypes of Alleles Possibly Associated With Adverse Hepatic Drug Reactions (Pharmacogenomic Evaluable Population)

    The frequency of the candidate gene alleles, HLA-DQA1*02:01, HLA-DQB1*02:02, HLA-DRB1*07:01 and TNXB/rs12153855, were measured in alanine transaminase (ALT) Cases and ALT Controls to evaluate if there were statistically significant associations that would support or suggest any predictive (ie, diagnostic) value of these markers in identifying participants who were at increased risk for hepatic toxicity. The frequency of 2 additional HLA gene alleles, HLA-B*57:01 and HLA-DRB1*15:01, were also measured in ALT Cases and ALT Controls. ALT Cases are defined as those patients with a baseline ALT of ≤1xULN and at least one on-treatment ALT assessment of >3x upper limit of normal (ULN), and ALT Controls represent those patients with baseline and on-treatment assessments of ALT of ≤1xULN.

    Measured: 6 years

  10. QTc Prolongation in Participants

    The percentage of participants with maximum post-dose QTcF/QTcB (<450, 450 - <480, 480 - <500, and ≥500 msec) were evaluated.

    Measured: 6 years

  11. Mean Change From Baseline in QLQ-C30 Global Quality of Life Scores.

    The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.

    Measured: 6 years

  12. Mean Change From Baseline of EORTC QLQ-C30 Functional and Symptom Scale Scores

    The EORTC QLQ-C30 consists of 30 questions which assess five functional domains (physical, role, cognitive, emotional, and social), global health status/quality of life, disease/treatment related symptoms (fatigue, pain, nausea/vomiting, dyspnoea, appetite loss, sleep disturbance, constipation, and diarrhoea), and the perceived financial impact of disease. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-C30 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.

    Measured: 6 years

  13. Mean Change From Baseline of QLQ-LC13 Scale Scores

    The QLQ-LC13 consists of 1 multi-item scale and 9 single items that assess specific symptoms (dyspnoea, cough, hemoptysis, and site-specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer patients. n is the number of participants who completed the scale at baseline and at the respective Cycle. The subscales of the EORTC QLQ-LC13 were scored based on the EORTC scoring manual. The transformed scores range from 0-100. Higher scores indicate higher ("worse") symptom severity, higher ("better") functioning, and better global QoL. Negative change from Baseline scores indicate an improvement in symptoms, decreased functioning, or decreased QoL, while positive change scores indicate an increase in functioning, increased QoL, or deterioration in symptoms.

    Measured: 6 years

  14. Percentage of Participants With Visual Symptom Assessment Questionnaire (VSAQ-ALK)

    The participants who responded to the question: "Have you experienced any visual disturbances?" Only the participants who answered yes were instructed to complete the rest of the questionnaire. N was the number of participants who had completed the first question.

    Measured: 6 years

  15. Patient Reported Outcomes (PROs) of Health-related Quality of Life (HRQoL): Mean Change From Baseline of EQ-5D Visual Analog Score (VAS) Scale

    The EQ-5D descriptive system measured a patient's health state on 5 dimensions which included: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondent's self-rated health was assessed on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state) by the EQ-VAS. n is the number of participants who completed the scale at baseline and at the respective Cycle.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionMar 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Masking
None (open label)
Enrolment
1,069 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00932451
Sponsor's protocol ID
A8081005
Other IDs
2009-012504-13, 2009
Status last verified
Nov 2016
First submitted
30 Jun 2009
Last updated
13 Jan 2017
Data monitoring committee
Yes

Publications

  • Camidge DR, Kim EE, Usari T, Polli A, Lewis I, Wilner KD. Renal Effects of Crizotinib in Patients With ALK-Positive Advanced NSCLC. J Thorac Oncol. 2019 Jun;14(6):1077-1085. doi: 10.1016/j.jtho.2019.02.015. Epub 2019 Feb 26.

    PubMed 30822515

  • Blackhall F, Ross Camidge D, Shaw AT, Soria JC, Solomon BJ, Mok T, Hirsh V, Janne PA, Shi Y, Yang PC, Pas T, Hida T, Carpeno JC, Lanzalone S, Polli A, Iyer S, Reisman A, Wilner KD, Kim DW. Final results of the large-scale multinational trial PROFILE 1005: efficacy and safety of crizotinib in previously treated patients with advanced/metastatic ALK-positive non-small-cell lung cancer. ESMO Open. 2017 Aug 17;2(3):e000219. doi: 10.1136/esmoopen-2017-000219. eCollection 2017.

    PubMed 29209525

  • Yoneda KY, Scranton JR, Cadogan MA, Tassell V, Nadanaciva S, Wilner KD, Stollenwerk NS. Interstitial Lung Disease Associated With Crizotinib in Patients With Advanced Non-Small Cell Lung Cancer: Independent Review of Four PROFILE Trials. Clin Lung Cancer. 2017 Sep;18(5):472-479. doi: 10.1016/j.cllc.2017.03.004. Epub 2017 Mar 14.

    PubMed 28373069

  • Lin YT, Yu CJ, Yang JC, Shih JY. Anaplastic Lymphoma Kinase (ALK) Kinase Domain Mutation Following ALK Inhibitor(s) Failure in Advanced ALK Positive Non-Small-Cell Lung Cancer: Analysis and Literature Review. Clin Lung Cancer. 2016 Sep;17(5):e77-e94. doi: 10.1016/j.cllc.2016.03.005. Epub 2016 Mar 30.

    PubMed 27130468

  • Costa DB, Shaw AT, Ou SH, Solomon BJ, Riely GJ, Ahn MJ, Zhou C, Shreeve SM, Selaru P, Polli A, Schnell P, Wilner KD, Wiltshire R, Camidge DR, Crino L. Clinical Experience With Crizotinib in Patients With Advanced ALK-Rearranged Non-Small-Cell Lung Cancer and Brain Metastases. J Clin Oncol. 2015 Jun 10;33(17):1881-8. doi: 10.1200/JCO.2014.59.0539. Epub 2015 Jan 26.

    PubMed 25624436

  • Lin YT, Wang YF, Yang JC, Yu CJ, Wu SG, Shih JY, Yang PC. Development of renal cysts after crizotinib treatment in advanced ALK-positive non-small-cell lung cancer. J Thorac Oncol. 2014 Nov;9(11):1720-5. doi: 10.1097/JTO.0000000000000326.

    PubMed 25436806

  • Ou SH. Crizotinib: a drug that crystallizes a unique molecular subset of non-small-cell lung cancer. Expert Rev Anticancer Ther. 2012 Feb;12(2):151-62. doi: 10.1586/era.11.186.

    PubMed 22316363

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-02341066 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 280 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 280 sites in United States, Canada, Italy, Spain, Japan and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (time frame: 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00932451, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.

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