Status:
COMPLETED
Sorafenib Gastric Cancer Asian Phase I Study
Lead Sponsor:
Bayer
Conditions:
Gastric Cancer
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cance...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed.
- 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
- Known brain metastasis, spinal cord compression or meningeal carcinomatosis.
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00663741
Start Date
May 1 2008
End Date
April 1 2010
Last Update
June 11 2013
Active Locations (3)
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1
Kashiwa, Chiba, Japan, 277-8577
2
Kobe, Hyōgo, Japan, 650-0017
3
Chuo-ku, Tokyo, Japan, 104-0045