Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
NCT ID: NCT00195260
Last Updated: 2013-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
151 participants
INTERVENTIONAL
2004-10-31
2007-11-30
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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Dose escalation
Dose finding study of monotherapy bosutinib in patients with advanced solid tumors.
bosutinib
Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.
Colorectal Cancer
Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
bosutinib
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Pancreatic Cancer
Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
bosutinib
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Non-Small Cell Lung Cancer (NSCLC)
Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
bosutinib
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Interventions
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bosutinib
Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen.
bosutinib
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
bosutinib
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
bosutinib
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
* Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* Other inclusion applies.
Exclusion Criteria
* Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1).
* Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for \>= 2 weeks before day 1).
* Other exclusion applies.
18 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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Pfizer Investigational Site
Birmington, Alabama, United States
Pfizer Investigational Site
Scottsdale, Arizona, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Indianpolis, Indiana, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Lansing, Michigan, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
UNC Chapel Hill, North Carolina, United States
Pfizer Investigational Site
UNC Chapel Hill, North Carolina, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Tyler, Texas, United States
Pfizer Investigational Site
Seattle, Washington, United States
Countries
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References
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Hsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10.
Other Identifiers
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B1871012
Identifier Type: -
Identifier Source: secondary_id
3160A1-100
Identifier Type: -
Identifier Source: org_study_id
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