Phase II Study of ABI-007 for Gastric Cancer

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

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