Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)
NCT ID: NCT01121588
Last Updated: 2025-01-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
44 participants
INTERVENTIONAL
2011-03-22
2023-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crizotinib
Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Interventions
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Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* positive for translocation or inversion event involving the ALK gene locus
* positive for ALK amplification events
* positive for ALK activating point mutations
Exclusion Criteria
* concurrent treatment on another therapeutic clinical trial
* prior therapy specifically directed against ALK
15 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Highlands Oncology Group
Fayetteville, Arkansas, United States
Highlands Oncology Group
Rogers, Arkansas, United States
Highland Oncology Group
Springdale, Arkansas, United States
Washington University School of Medicine
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
OHSU Center for Health and Healing 2
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Greenville Health System, Institute for Translational Oncology Research
Greenville, South Carolina, United States
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Chaoyang District, China
SUN Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Centro di Ricerca di Fase 1 ASST-Monza
Monza, , Italy
PO San Gerardo, ASST Monza-U.O Ematologia
Monza, , Italy
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
GBOU VPO "First Saint-Petersburg State Medical University n.a.I.P Pavlov" Ministry of Health
Saint Petersburg, , Russia
Institute of Pedriatric Oncology, Hematology and Transplantation n.a R.M Gorbacheva
Saint Petersburg, , Russia
Seoul National University Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
National Taiwan University Hospital, Department of Internal Medicine
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-022978-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8081013
Identifier Type: -
Identifier Source: org_study_id
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