Phase II Study of ABI-007 for Gastric Cancer

Taiho Pharma

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: ABI-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661167

Taiho10041040

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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56 participants in 1 patient group

1

Experimental group

Description:

ABI-007

Treatment:

Drug: ABI-007