Gastric Cancer
Conditions
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 fluoropyrimidine and developed disease progression or recurrence.
Interventions
DRUGABI-007
ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | During chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Safety | During chemotherapy |
| Progression-free survival | Until progression |
| Overall survival | Over a year form randomaization |
| Disease control rate | Duration chemoterapy |
Countries
Japan
Outcome results
None listed