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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COMPLETED
PHASE1
13 participants
INTERVENTIONAL
2008-05-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 2 weeks off) + CDDP (60 mg/m2 on Day 8) / 35 days / cycle
Arm 2
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (25 mg/m2 bid, 3weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days / cycle
Arm 3
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days cycle
Interventions
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Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 2 weeks off) + CDDP (60 mg/m2 on Day 8) / 35 days / cycle
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (25 mg/m2 bid, 3weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days / cycle
Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days cycle
Eligibility Criteria
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Inclusion Criteria
* No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease
* Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies
* Age \>/= 18 years and \< 75 years
Exclusion Criteria
* Clinically relevant ascites
* Concurrent cancer that is distinct in primary site or histology from gastric cancer
* Any condition that impairs patient's ability to swallow whole pills
18 Years
74 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Yakuhin, Ltd.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Kashiwa, Chiba, Japan
Kobe, Hyōgo, Japan
Chuo-ku, Tokyo, Japan
Countries
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Other Identifiers
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12931
Identifier Type: -
Identifier Source: org_study_id
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