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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00932893
First received: June 30, 2009
Last updated: February 11, 2013
Last verified: February 2013
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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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| 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 | |
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| 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 | |
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| 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 | |
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| Palo Alto, California, United States, 94305 | |
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| Sacramento, California, United States, 95817 | |
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| San Diego, California, United States, 92103 | |
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| Santa Monica, California, United States, 90404 | |
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| Santa Rosa, California, United States, 95403 | |
| United States, Colorado | |
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| Aurora, Colorado, United States, 80045 | |
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| Denver, Colorado, United States, 80205 | |
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| Lafayette, Colorado, United States, 80026 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06510 | |
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| New Haven, Connecticut, United States, 06520 | |
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| New Haven, Connecticut, United States, 06519 | |
| United States, Florida | |
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| Hollywood, Florida, United States, 33021 | |
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| Lake Worth, Florida, United States, 33461 | |
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| Pembroke Pines, Florida, United States, 33028 | |
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| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
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| Atlanta, Georgia, United States, 30322 | |
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| Atlanta, Georgia, United States, 30308 | |
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| Atlanta, Georgia, United States, 30341 | |
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| Decatur, Georgia, United States, 30033 | |
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| Macon, Georgia, United States, 31217 | |
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| Marietta, Georgia, United States, 30060 | |
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| Sandy Springs, Georgia, United States, 30342 | |
| United States, Hawaii | |
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| Honolulu, Hawaii, United States, 96813 | |
| United States, Illinois | |
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| Chicago, Illinois, United States, 60612 | |
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| Chicago, Illinois, United States, 60637 | |
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| Harvey, Illinois, United States, 60426 | |
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| Tinley Park, Illinois, United States, 60477 | |
| United States, Indiana | |
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| Hobart, Indiana, United States, 46342 | |
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| Indianapolis, Indiana, United States, 46290 | |
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| Indianapolis, Indiana, United States, 46202 | |
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| Munster, Indiana, United States, 46321 | |
| United States, Maryland | |
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| Baltimore, Maryland, United States, 21231 | |
| United States, Massachusetts | |
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| Boston, Massachusetts, United States, 02215 | |
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| Boston, Massachusetts, United States, 02114 | |
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| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
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| Detroit, Michigan, United States, 48201 | |
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| Farmington Hills, Michigan, United States, 48334 | |
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| Creve Coeur, Missouri, United States, 63141 | |
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| St. Louis, Missouri, United States, 63110-1094 | |
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| St. Louis, Missouri, United States, 63110 | |
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| St. Peters, Missouri, United States, 63376 | |
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| Lebanon, New Hampshire, United States, 03756-0001 | |
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| Lake Success, New York, United States, 11042 | |
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| Manhasset, New York, United States, 11030 | |
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| New Hyde Park, New York, United States, 11040 | |
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| New York, New York, United States, 10021 | |
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| New York, New York, United States, 10022` | |
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| New York, New York, United States, 10032 | |
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| Oneida, New York, United States, 13421 | |
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| Oswego, New York, United States, 13126 | |
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| Syracuse, New York, United States, 13210 | |
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| Syracuse, New York, United States, 13210-2306 | |
| United States, North Carolina | |
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| Chapel Hill, North Carolina, United States, 27514 | |
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| Chapel Hill, North Carolina, United States, 27599-7600 | |
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| Cleveland, Ohio, United States, 44195 | |
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| Columbus, Ohio, United States, 43205 | |
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| Columbus, Ohio, United States, 43221 | |
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| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
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| Beaverton, Oregon, United States, 97006 | |
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| Gresham, Oregon, United States, 97030 | |
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| Portland, Oregon, United States, 97239 | |
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| Portland, Oregon, United States, 97210 | |
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| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
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| Hershey, Pennsylvania, United States, 17033-0850 | |
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| Philadelphia, Pennsylvania, United States, 19111 | |
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| Philadelphia, Pennsylvania, United States, 19104 | |
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| Pittsburgh, Pennsylvania, United States, 15232 | |
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| East Providence, Rhode Island, United States, 02914 | |
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| 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 | |
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| Nashville, Tennessee, United States, 37211 | |
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| Nashville, Tennessee, United States, 37232-7610 | |
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| Nashville, Tennessee, United States, 37203 | |
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| Nashville, Tennessee, United States, 37205 | |
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| Nashville, Tennessee, United States, 37232-5536 | |
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| Smyrna, Tennessee, United States, 37167 | |
| United States, Texas | |
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| Houston, Texas, United States, 77030 | |
| United States, Washington | |
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| Seattle, Washington, United States, 98109 | |
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| Seattle, Washington, United States, 98122 | |
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| Seattle, Washington, United States, 98104 | |
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| 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 | |
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| Nedlands, Western Australia, Australia, 6009 | |
| Brazil | |
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| Salvador, BA, Brazil, 40170-110 | |
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| Rio de Janeiro, RJ, Brazil, 20231 -050 | |
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| Ijui, RS, Brazil, 98700-000 | |
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| Porto Alegre, RS, Brazil, 90050-170 | |
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| Porto Alegre, RS, Brazil, 90610-000 | |
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| Jau, Sao Paulo, Brazil, 17210-120 | |
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| Barretos, SP, Brazil, 14784-400 | |
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| Sao Paulo, SP, Brazil, 01246-000 | |
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| Sao Paulo, SP, Brazil, 01509-900 | |
| Bulgaria | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| Oshawa, Ontario, Canada, L1J 8N8 | |
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| Oshawa, Ontario, Canada, L1G 2B9 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| 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 | |
| Pfizer Investigational Site | |
| 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 | |
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| Beijing, China, 100021 | |
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| Shanghai, China, 200030 | |
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| Shanghai, China, 200032 | |
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| Shanghai, China, 200433 | |
| France | |
| Pfizer Investigational Site | |
| Argenteuil Cedex, France, 95107 | |
| Pfizer Investigational Site | |
| Boulogne-Billancourt, France, 92100 | |
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| Caen Cedex 05, France, 14076 | |
| Pfizer Investigational Site | |
| Créteil, France, 94000 | |
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| Dijon, France, 21079 | |
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| Grenoble Cedex 09, France, 38043 | |
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| Longjumeau Cedex 01, France, 91161 | |
| Pfizer Investigational Site | |
| Marseille Cedex 20, France, 13915 | |
| Pfizer Investigational Site | |
| NICE Cedex 2, France, 06189 | |
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| Paris, France, 75005 | |
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| Paris Cedex 12, France, 75571 | |
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| Paris Cedex 14, France, 75679 | |
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| Paris cedex 20, France, 75970 | |
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| St Herblain Cedex, France, 44805 | |
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| Suresnes, France, 92150 | |
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| Villejuif, France, 94805 | |
| Germany | |
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| Dresden, Germany, 01307 | |
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| Essen, Germany, 45122 | |
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| Grosshansdorf, Germany, 22927 | |
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| Hamburg, Germany, 22527 | |
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| Heidelberg, Germany, 69126 | |
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| Karlsruhe, Germany, 76137 | |
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| Koeln, Germany, 50937 | |
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| Muenchen, Germany, 80336 | |
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| Oldenburg, Germany, 26121 | |
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| Wiesbaden, Germany, 65199 | |
| Greece | |
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| Heraklion, Crete, Greece, 71110 | |
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| Exohi, Thessaloniki, Greece, 57010 | |
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| Athens, Greece, 11527 | |
| Hong Kong | |
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| Pokfulam, Hong Kong | |
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| Shatin, New Territories, Hong Kong | |
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| Tuen Mun, New Territories, Hong Kong | |
| Hungary | |
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| Budapest, Hungary, 1125 | |
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| Budapest, Hungary, 1121 | |
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| Debrecen, Hungary, 4032 | |
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| Farkasgyepu, Hungary, 8582 | |
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| Szekesfehervar, Hungary, 8000 | |
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| Torokbalint, Hungary, 2045 | |
| Ireland | |
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| Dublin 8, Ireland | |
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| Galway, Ireland | |
| Italy | |
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| Avellino, Italy, 83100 | |
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| Firenze, Italy, 50139 | |
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| Genova, Italy, 16132 | |
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| Lido di Camaiore (LU), Italy, 55043 | |
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| Lucca, Italy, 55100 | |
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| Milano, Italy, 20141 | |
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| Milano, Italy, 20132 | |
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| Milano, Italy, 20162 | |
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| Monza, Italy, 20052 | |
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| Orbassano (TO), Italy, 10043 | |
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| Perugia, Italy, 06132 | |
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| Roma, Italy, 00152 | |
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| Torino, Italy, 10126 | |
| Japan | |
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| Nagoya, Aichi, Japan | |
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| Kashiwa, Chiba, Japan | |
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| Sapporo, Hokkaido, Japan | |
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| Akashi, Hyogo, Japan | |
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| Okayama-city, Okayama, Japan | |
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| Osakasayama-shi, Osaka, Japan | |
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| Sunto-gun, Shizuoka, Japan | |
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| Chuo-ku, Tokyo, Japan | |
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| Fukuoka, Japan | |
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| Tokyo, Japan | |
| Korea, Republic of | |
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| Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
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| Seoul, Korea, Republic of, 110-744 | |
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| Seoul, Korea, Republic of, 135-710 | |
| Netherlands | |
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| Groningen, Netherlands, 9713 GZ | |
| Poland | |
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| Gdansk, Poland, 80-952 | |
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| Olsztyn, Poland, 10-357 | |
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| Otwock, Poland, 05-400 | |
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| Poznan, Poland, 60-569 | |
| Russian Federation | |
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| Kazan, Russian Federation, 420029 | |
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| Moscow, Russian Federation, 115478 | |
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| Saint-Peterburg, Russian Federation, 197089 | |
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| Saint-Petersburg, Russian Federation, 197022 | |
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| Sochi, Russian Federation, 354057 | |
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| St. Petersburg, Russian Federation, 198255 | |
| Spain | |
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| Oviedo, Asturias, Spain, 33006 | |
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| Badalona, Barcelona, Spain, 08916 | |
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| L'hospitalet de Llobregat, Barcelona, Spain, 08907 | |
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| Sabadell, Barcelona, Spain, 08208 | |
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| Pamplona, Navarra, Spain, 31008 | |
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| A Coruña, Spain, 15006 | |
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| Barcelona, Spain, 08003 | |
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| Barcelona, Spain, 08035 | |
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| Madrid, Spain, 28046 | |
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| Santander, Spain, 39008 | |
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| Sevilla, Spain, 41013 | |
| Sweden | |
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| Stockholm, Sweden, 171 76 | |
| Taiwan | |
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| Tainan, Taiwan, 704 | |
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| Taipei, Taiwan, 112 | |
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| Taipei, Taiwan, 100 | |
| United Kingdom | |
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| Sutton, Surrey, United Kingdom, SM2 5PT | |
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| Eastleigh, United Kingdom, SO53 2DW | |
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| London, United Kingdom, NW3 2QG | |
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| London, United Kingdom, SE1 9RT | |
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| London, United Kingdom, SW3 6JJ | |
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| Manchester, United Kingdom, M20 4BX | |
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| Oxford, United Kingdom, OX3 7LJ | |
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| 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