Trial Condition(s):

Gastric Cancer

Sorafenib Gastric Cancer Asian Phase I study

Bayer Identifier:

12931

ClinicalTrials.gov Identifier:

NCT00663741

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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 cancer.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
13
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

National Cancer Center Central Hospital

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

Kobe University Hospital

Kobe, Japan, 650-0017

Status
Completed
 

Trial Design