Status:
COMPLETED
Study of Cediranib Plus Cisplatin Plus Capecitabine/S-1 in Japanese Gastric Cancer Patients
Lead Sponsor:
AstraZeneca
Conditions:
Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The primary objective of the study is to assess the safety and tolerability of cediranib in combination with Cisplatin plus a Fluoropyrimidine (Capecitabine or S-1) in Japanese patients with previousl...
Eligibility Criteria
Inclusion
- Histological or cytological confirmation of gastric adenocarcinoma (including the gastric cardia and esophagogastric junction)
- Having locally advanced or metastatic gastric cancer for which they must have received no prior systemic therapy for locally advanced disease. Previous gastrectomy, neoadjuvant and adjuvant therapy received \> 6 months ago are acceptable
- Having a mild symptom in ordinal daily lives including walking and simple labour or works in the sitting position
Exclusion
- A history of poorly controlled hypertension or resting BP \> 150/100 mmHg in the presence or absence of a stable regimen of anti-hypertensive therapy or patients who are requiring maximal doses of calcium channel blockers to stabilize BP
- Significant Haemorrhage (\> 30 ml bleeding/episode in previous 3 months) or haemoptysis (\> 5 ml fresh blood in previous 4 weeks)
- Arterial thromboembolic event (including ischemic attack) in the previous 12 months
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00960349
Start Date
August 1 2009
End Date
March 1 2011
Last Update
June 14 2011
Active Locations (4)
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1
Research Site
Nagoya, Aichi-ken, Japan
2
Research Site
Sayama, Osaka, Japan
3
Research Site
Sunto-gun, Shizuoka, Japan
4
Research Site
Chūō, Tokyo, Japan