Sorafenib Gastric Cancer Asian Phase I Study

Bayer

Status and phase

Completed

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: Sorafenib (Nexavar, BAY43-9006)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00663741

12931

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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