Phase II Study of ABI-007 for Gastric Cancer

January 16, 2012 updated by: Taiho Pharmaceutical Co., Ltd.

Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 811- 1395
        • National Kyusyu Cancer Center
      • Kochi, Japan, 781- 855
        • Kochi Health Sciences Center
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center
    • Ehime
      • Matsuyama, Ehime, Japan, 791- 0280
        • Shikoku Cancer Center
    • Kanagawa
      • Sagamihara, Kanagawa, Japan, 228-8520
        • Kitasato University East Hospital
    • Nagano
      • Saku, Nagano, Japan, 384-0301
        • Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare
    • Osaka
      • Takatsuki, Osaka, Japan, 569- 8686
        • Osaka Medical College Hospital
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama International medical center-comprehensive cancer center, Saitama Medical University
    • Shizuoka
      • Sunto, Shizuoka, Japan, 411- 8777
        • Shizuoka Cancer Center
    • Toyama
      • Takaoka, Toyama, Japan, 933- 8555
        • Kouseiren Takaoka Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
ABI-007
Drug: ABI-007
ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: During chemotherapy
During chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety
Time Frame: During chemotherapy
During chemotherapy
Progression-free survival
Time Frame: Until progression
Until progression
Overall survival
Time Frame: Over a year form randomaization
Over a year form randomaization
Disease control rate
Time Frame: Duration chemoterapy
Duration chemoterapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Nagahiro Saijo, MD, Kinki University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 18, 2012

Last Update Submitted That Met QC Criteria

January 16, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Taiho10041040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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