Status:
COMPLETED
Phase II Study of ABI-007 for Gastric Cancer
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tri-weekly ABI-007 for recurrence or unresectable gastric cancer patients who have received one prior regimen containing fluoropyrim...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed gastric adenocarcinoma
- Received one prior regimen containing fluoropyrimidine analogs and developed disease progression or recurrence
- Age: 20 - 74
- At least one measurable lesion by RECIST criteria
Exclusion
- History of Taxans use
- Patients with another active malignancy
- Pre-existing peripheral neuropathy of Grade 2, 3, or 4 (per CTCAE)
- Chronic treatment with steroids
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00661167
Start Date
April 1 2008
End Date
December 1 2011
Last Update
January 18 2012
Active Locations (10)
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1
Aichi Cancer Center
Nagoya, Aichi-ken, Japan, 464-8681
2
Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791- 0280
3
National Kyusyu Cancer Center
Fukuoka, Fukuoka, Japan, 811- 1395
4
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520