Trial record 2 of 2 for:    A8081007

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932893
First received: June 30, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This is a Phase 3 trial comparing the safety and anti-tumor activity of PF-02341066 versus pemetrexed or docetaxel in patients with advanced non-small lung cancer with specific gene profile involving the ALK gene after failure of one previous chemotherapy regimen that included one platinum drug.


Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung
Drug: PF-02341066
Drug: Pemetrexed
Drug: Docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3, Randomized, Open-Label Study Of The Efficacy And Safety Of PF-02341066 Versus Standard Of Care Chemotherapy (Pemetrexed Or Docetaxel) In Patients With Non-Small Lung Cancer Harboring A Translocation Or Inversion Event Involving The Anaplastic Lymphoma Kinase (ALK) Gene Locus

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression-Free Survival (PFS) of PF-02341066 vs Pemetrexed or Docetaxel [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective Response Rate [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: 23 months ] [ Designated as safety issue: No ]
  • Disease Control Rate [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Patient reported symptoms of lung cancer and health-related quality of life [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Type, incidence, severity, seriousness and relationship to study medication of adverse events and laboratory test abnormalities [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Plasma concentrations of PF-02341066 [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Types of EML4-ALK fusion variants and ALK gene expression [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of pharmacodynamic biomarkers [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • QTc [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]
  • Time to Tumor Response [ Time Frame: 23 months ] [ Designated as safety issue: No ]

Enrollment: 347
Study Start Date: September 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-02341066 Drug: PF-02341066
PF-02341066, 250 mg BID will be administered orally on a continuous schedule
Active Comparator: Pemetrexed or Docetaxel
Investigator selection of either pemetrexed or docetaxel as the active comparator
Drug: Pemetrexed
Pemetrexed, 500 mg/m2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle
Drug: Docetaxel
Docetaxel, 75 mg/m2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by a central laboratory)
  • must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum drug
  • tumors must be measurable

Exclusion Criteria:

  • prior treatment with PF-02341066
  • current treatment in another clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932893

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Locations
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Bakersfield, California, United States, 93309
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
Pfizer Investigational Site
Beverly Hills, California, United States, 90211-1850
Pfizer Investigational Site
La Jolla, California, United States, 92093-0698
Pfizer Investigational Site
La Jolla, California, United States, 92037
Pfizer Investigational Site
Los Angeles, California, United States, 90095
Pfizer Investigational Site
Los Angeles, California, United States, 90095-6984
Pfizer Investigational Site
Los Angeles, California, United States, 90404
Pfizer Investigational Site
Orange, California, United States, 92868-3298
Pfizer Investigational Site
Palo Alto, California, United States, 94305
Pfizer Investigational Site
Sacramento, California, United States, 95817
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
Santa Monica, California, United States, 90404
Pfizer Investigational Site
Santa Rosa, California, United States, 95403
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
Pfizer Investigational Site
Denver, Colorado, United States, 80205
Pfizer Investigational Site
Lafayette, Colorado, United States, 80026
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
United States, Florida
Pfizer Investigational Site
Hollywood, Florida, United States, 33021
Pfizer Investigational Site
Lake Worth, Florida, United States, 33461
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33028
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30322
Pfizer Investigational Site
Atlanta, Georgia, United States, 30308
Pfizer Investigational Site
Atlanta, Georgia, United States, 30341
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Macon, Georgia, United States, 31217
Pfizer Investigational Site
Marietta, Georgia, United States, 30060
Pfizer Investigational Site
Sandy Springs, Georgia, United States, 30342
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Harvey, Illinois, United States, 60426
Pfizer Investigational Site
Tinley Park, Illinois, United States, 60477
United States, Indiana
Pfizer Investigational Site
Hobart, Indiana, United States, 46342
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46290
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
Pfizer Investigational Site
Munster, Indiana, United States, 46321
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
Pfizer Investigational Site
Farmington Hills, Michigan, United States, 48334
United States, Missouri
Pfizer Investigational Site
Creve Coeur, Missouri, United States, 63141
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110-1094
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
St. Peters, Missouri, United States, 63376
United States, New Hampshire
Pfizer Investigational Site
Lebanon, New Hampshire, United States, 03756-0001
United States, New York
Pfizer Investigational Site
Lake Success, New York, United States, 11042
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Manhasset, New York, United States, 11030
Pfizer Investigational Site
New Hyde Park, New York, United States, 11040
Pfizer Investigational Site
New York, New York, United States, 10021
Pfizer Investigational Site
New York, New York, United States, 10022`
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
Oneida, New York, United States, 13421
Pfizer Investigational Site
Oswego, New York, United States, 13126
Pfizer Investigational Site
Syracuse, New York, United States, 13210
Pfizer Investigational Site
Syracuse, New York, United States, 13210-2306
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27514
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599-7600
United States, Ohio
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Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
Pfizer Investigational Site
Columbus, Ohio, United States, 43221
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Oregon
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Beaverton, Oregon, United States, 97006
Pfizer Investigational Site
Gresham, Oregon, United States, 97030
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Portland, Oregon, United States, 97239
Pfizer Investigational Site
Portland, Oregon, United States, 97210
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Tualatin, Oregon, United States, 97062
United States, Pennsylvania
Pfizer Investigational Site
Hershey, Pennsylvania, United States, 17033-0850
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Philadelphia, Pennsylvania, United States, 19111
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
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Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02915
United States, Tennessee
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Dickson, Tennessee, United States, 37055
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Franklin, Tennessee, United States, 37067
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Gallatin, Tennessee, United States, 37066
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Hermitage, Tennessee, United States, 37076
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Lebanon, Tennessee, United States, 37087
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Murfreesboro, Tennessee, United States, 37130
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Nashville, Tennessee, United States, 37207
Pfizer Investigational Site
Nashville, Tennessee, United States, 37211
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-7610
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
Pfizer Investigational Site
Nashville, Tennessee, United States, 37205
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232-5536
Pfizer Investigational Site
Smyrna, Tennessee, United States, 37167
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98109
Pfizer Investigational Site
Seattle, Washington, United States, 98122
Pfizer Investigational Site
Seattle, Washington, United States, 98104
Pfizer Investigational Site
Seattle, Washington, United States, 98195
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site
East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Brazil
Pfizer Investigational Site
Salvador, BA, Brazil, 40170-110
Pfizer Investigational Site
Rio de Janeiro, RJ, Brazil, 20231 -050
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Ijui, RS, Brazil, 98700-000
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90050-170
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Pfizer Investigational Site
Jau, Sao Paulo, Brazil, 17210-120
Pfizer Investigational Site
Barretos, SP, Brazil, 14784-400
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01246-000
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Sao Paulo, SP, Brazil, 01509-900
Bulgaria
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Plovdiv, Bulgaria, 4004
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Sofia, Bulgaria, 1527
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Sofia, Bulgaria, 1606
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Sofia, Bulgaria, 1756
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Varna, Bulgaria, 9002
Canada, Alberta
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Calgary, Alberta, Canada, T2S 3C3
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Calgary, Alberta, Canada, T2N 4N2
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Calgary, Alberta, Canada, T2V 2C4
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, New Brunswick
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Moncton, New Brunswick, Canada, E1C 2Z3
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Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
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Oshawa, Ontario, Canada, L1J 8N8
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Oshawa, Ontario, Canada, L1G 2B9
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Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Montreal, Quebec, Canada, H3G 1A4
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Montreal, Quebec, Canada, H3T 1M5
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Montreal, Quebec, Canada, H3T 1E2
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Montreal, Quebec, Canada, H2L 4M1
China, Guangdong
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510080
Pfizer Investigational Site
Guangzhou, Guangdong, China, 510060
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210002
China
Pfizer Investigational Site
Beijing, China, 100071
Pfizer Investigational Site
Beijing, China, 100021
Pfizer Investigational Site
Shanghai, China, 200030
Pfizer Investigational Site
Shanghai, China, 200032
Pfizer Investigational Site
Shanghai, China, 200433
France
Pfizer Investigational Site
Argenteuil Cedex, France, 95107
Pfizer Investigational Site
Boulogne-Billancourt, France, 92100
Pfizer Investigational Site
Caen Cedex 05, France, 14076
Pfizer Investigational Site
Créteil, France, 94000
Pfizer Investigational Site
Dijon, France, 21079
Pfizer Investigational Site
Grenoble Cedex 09, France, 38043
Pfizer Investigational Site
Longjumeau Cedex 01, France, 91161
Pfizer Investigational Site
Marseille Cedex 20, France, 13915
Pfizer Investigational Site
NICE Cedex 2, France, 06189
Pfizer Investigational Site
Paris, France, 75005
Pfizer Investigational Site
Paris Cedex 12, France, 75571
Pfizer Investigational Site
Paris Cedex 14, France, 75679
Pfizer Investigational Site
Paris cedex 20, France, 75970
Pfizer Investigational Site
St Herblain Cedex, France, 44805
Pfizer Investigational Site
Suresnes, France, 92150
Pfizer Investigational Site
Villejuif, France, 94805
Germany
Pfizer Investigational Site
Dresden, Germany, 01307
Pfizer Investigational Site
Essen, Germany, 45122
Pfizer Investigational Site
Grosshansdorf, Germany, 22927
Pfizer Investigational Site
Hamburg, Germany, 22527
Pfizer Investigational Site
Heidelberg, Germany, 69126
Pfizer Investigational Site
Karlsruhe, Germany, 76137
Pfizer Investigational Site
Koeln, Germany, 50937
Pfizer Investigational Site
Muenchen, Germany, 80336
Pfizer Investigational Site
Oldenburg, Germany, 26121
Pfizer Investigational Site
Wiesbaden, Germany, 65199
Greece
Pfizer Investigational Site
Heraklion, Crete, Greece, 71110
Pfizer Investigational Site
Exohi, Thessaloniki, Greece, 57010
Pfizer Investigational Site
Athens, Greece, 11527
Hong Kong
Pfizer Investigational Site
Pokfulam, Hong Kong
Pfizer Investigational Site
Shatin, New Territories, Hong Kong
Pfizer Investigational Site
Tuen Mun, New Territories, Hong Kong
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1125
Pfizer Investigational Site
Budapest, Hungary, 1121
Pfizer Investigational Site
Debrecen, Hungary, 4032
Pfizer Investigational Site
Farkasgyepu, Hungary, 8582
Pfizer Investigational Site
Szekesfehervar, Hungary, 8000
Pfizer Investigational Site
Torokbalint, Hungary, 2045
Ireland
Pfizer Investigational Site
Dublin 8, Ireland
Pfizer Investigational Site
Galway, Ireland
Italy
Pfizer Investigational Site
Avellino, Italy, 83100
Pfizer Investigational Site
Firenze, Italy, 50139
Pfizer Investigational Site
Genova, Italy, 16132
Pfizer Investigational Site
Lido di Camaiore (LU), Italy, 55043
Pfizer Investigational Site
Lucca, Italy, 55100
Pfizer Investigational Site
Milano, Italy, 20141
Pfizer Investigational Site
Milano, Italy, 20132
Pfizer Investigational Site
Milano, Italy, 20162
Pfizer Investigational Site
Monza, Italy, 20052
Pfizer Investigational Site
Orbassano (TO), Italy, 10043
Pfizer Investigational Site
Perugia, Italy, 06132
Pfizer Investigational Site
Roma, Italy, 00152
Pfizer Investigational Site
Torino, Italy, 10126
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Akashi, Hyogo, Japan
Pfizer Investigational Site
Okayama-city, Okayama, Japan
Pfizer Investigational Site
Osakasayama-shi, Osaka, Japan
Pfizer Investigational Site
Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Pfizer Investigational Site
Fukuoka, Japan
Pfizer Investigational Site
Tokyo, Japan
Korea, Republic of
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Netherlands
Pfizer Investigational Site
Groningen, Netherlands, 9713 GZ
Poland
Pfizer Investigational Site
Gdansk, Poland, 80-952
Pfizer Investigational Site
Olsztyn, Poland, 10-357
Pfizer Investigational Site
Otwock, Poland, 05-400
Pfizer Investigational Site
Poznan, Poland, 60-569
Russian Federation
Pfizer Investigational Site
Kazan, Russian Federation, 420029
Pfizer Investigational Site
Moscow, Russian Federation, 115478
Pfizer Investigational Site
Saint-Peterburg, Russian Federation, 197089
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 197022
Pfizer Investigational Site
Sochi, Russian Federation, 354057
Pfizer Investigational Site
St. Petersburg, Russian Federation, 198255
Spain
Pfizer Investigational Site
Oviedo, Asturias, Spain, 33006
Pfizer Investigational Site
Badalona, Barcelona, Spain, 08916
Pfizer Investigational Site
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Sabadell, Barcelona, Spain, 08208
Pfizer Investigational Site
Pamplona, Navarra, Spain, 31008
Pfizer Investigational Site
A Coruña, Spain, 15006
Pfizer Investigational Site
Barcelona, Spain, 08003
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Madrid, Spain, 28046
Pfizer Investigational Site
Santander, Spain, 39008
Pfizer Investigational Site
Sevilla, Spain, 41013
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Taiwan
Pfizer Investigational Site
Tainan, Taiwan, 704
Pfizer Investigational Site
Taipei, Taiwan, 112
Pfizer Investigational Site
Taipei, Taiwan, 100
United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT
Pfizer Investigational Site
Eastleigh, United Kingdom, SO53 2DW
Pfizer Investigational Site
London, United Kingdom, NW3 2QG
Pfizer Investigational Site
London, United Kingdom, SE1 9RT
Pfizer Investigational Site
London, United Kingdom, SW3 6JJ
Pfizer Investigational Site
Manchester, United Kingdom, M20 4BX
Pfizer Investigational Site
Oxford, United Kingdom, OX3 7LJ
Pfizer Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00932893     History of Changes
Other Study ID Numbers: A8081007
Study First Received: June 30, 2009
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Lung Neoplasms ALK gene crizotinib

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Lymphoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Docetaxel
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 23, 2013