Trial Condition(s):
Gastric Cancer
Sorafenib Gastric Cancer Asian Phase I study
Bayer Identifier:
12931
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations National Cancer Center Central Hospital Chuo-ku, Japan, 104-0045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Hospital East Kashiwa, Japan, 277-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kobe University Hospital Kobe, Japan, 650-0017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Phase I study to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib (BAY 43-9006) in combination with S-1 plus CDDP in Asian patients with unresectable / recurrent gastric cancer
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Safety and pharmacokineticsTimeframe: 20 weeks after start of treatment
Secondary Outcome
- 1 year survival rateTimeframe: 1 year after start of treatment
- Overall survivalTimeframe: 1 year after start of treatment
- Progression free survivalTimeframe: 1 year after start of treatment
- Response rateTimeframe: 1 year after start of treatment
- Duration of responseTimeframe: Time from initial Response to documented Tumor Progression
Additional Information
Copyright © Bayer
Powered by
