Phase II Study of ABI-007 for Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: ABI-007

• Registration Number: NCT00661167
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-18
• Primary Completion: 2011-05
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-16
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ABI-007	ABI-007

Primary Outcome Measures

Name	Time	Method
Overall response rate	During chemotherapy

Secondary Outcome Measures

Name	Time	Method
Safety	During chemotherapy
Progression-free survival	Until progression
Overall survival	Over a year form randomaization
Disease control rate	Duration chemoterapy

Trial Locations

Locations (10)

Kochi Health Sciences Center; 🇯🇵 Kochi, Japan

Aichi Cancer Center; 🇯🇵 Nagoya, Aichi, Japan

National Kyusyu Cancer Center; 🇯🇵 Fukuoka, Japan

Shizuoka Cancer Center; 🇯🇵 Sunto, Shizuoka, Japan

Saitama International medical center-comprehensive cancer center, Saitama Medical University; 🇯🇵 Hidaka, Saitama, Japan

Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare; 🇯🇵 Saku, Nagano, Japan

Shikoku Cancer Center; 🇯🇵 Matsuyama, Ehime, Japan

Kitasato University East Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan

Osaka Medical College Hospital; 🇯🇵 Takatsuki, Osaka, Japan

Kouseiren Takaoka Hospital; 🇯🇵 Takaoka, Toyama, Japan