Study Of Axitinib In Combination With Cisplatin And Capecitabine In Patients With Advanced Gastric Cancer
NCT ID: NCT00842244
Last Updated: 2013-11-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2009-04-30
2012-10-31
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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A
axitinib
Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
capecitabine
Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m\^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
cisplatin
Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m\^2 on day 1.
Interventions
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axitinib
Twice daily oral dose of axitinib continuously depending upon side effects observed. Starting dose is 5mg twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
capecitabine
Given orally twice daily for 14 days followed by 7 days of drug free period. Starting dose is 1000mg/m\^2 twice daily. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed.
cisplatin
Given through a vein on Day 1 of every 21 days. Each 21 day cycle is repeated until progression of disease or unacceptable toxicity is observed. The starting dose is 80 mg/m\^2 on day 1.
Eligibility Criteria
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Inclusion Criteria
* advanced stomach cancer of stage IV
* adequate blood chemistry, blood counts and kidney function
* willing to participate to study requirements and sign an informed consent document
Exclusion Criteria
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients
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
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Yufu, Oita Prefecture, Japan
Pfizer Investigational Site
Goyang-si, Gyeonggi-do, South Korea
Pfizer Investigational Site
Seongnam-si, Gyeonggi-do, South Korea
Pfizer Investigational Site
Seoul, , South Korea
Countries
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References
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Oh DY, Doi T, Shirao K, Lee KW, Park SR, Chen Y, Yang L, Valota O, Bang YJ. Phase I Study of Axitinib in Combination with Cisplatin and Capecitabine in Patients with Previously Untreated Advanced Gastric Cancer. Cancer Res Treat. 2015 Oct;47(4):687-96. doi: 10.4143/crt.2014.225. Epub 2015 Feb 12.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4061055
Identifier Type: -
Identifier Source: org_study_id