Sorafenib as a Second Line Treatment in Patients With Advanced or Metastatic Gastric Cancer
NCT ID: NCT00595985
Last Updated: 2009-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
5 participants
INTERVENTIONAL
2007-07-31
2009-01-31
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
administer sorafenib 400mg bid until disease progression or intolerable toxicity or patients withdrawal of consent
sorafenib
sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Interventions
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sorafenib
sorafenib 400mg bid, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance scale ≤ 2
* At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)
* Adequate hepatic, renal, heart, and hematologic functions:
* platelets\>80 × 109/L
* neutrophil\>2.0 × 109/L
* serum creatinine ≤ 1.5mg/dl
* total bilirubin within upper limit of normal(ULN)
* serum transaminase ≤ 2.5 × the ULN
Exclusion Criteria
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Uncontrolled significant comorbid conditions and previous radiotherapy
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Department of medical oncology, Cancer Hospital, Fuandan University
Principal Investigators
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Jin Li, PhD, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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Sorafenib-MGC
Identifier Type: -
Identifier Source: org_study_id
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