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Phase II Study of ABI-007 for Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00661167
First received: April 16, 2008
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: ABI-007
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of ABI-007 by Tri-weekly Schedule for Patients With Unresectable or Recurrent Gastric Cancer Refractory to 5-FU Containing Regimen.

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: During chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: During chemotherapy ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Until progression ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Over a year form randomaization ] [ Designated as safety issue: No ]
  • Disease control rate [ Time Frame: Duration chemoterapy ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: April 2008
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661167

Locations
Japan
Aichi Cancer Center
Nagoya, Aichi, Japan, 464-8681
Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791- 0280
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520
Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare
Saku, Nagano, Japan, 384-0301
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569- 8686
Saitama International medical center-comprehensive cancer center, Saitama Medical University
Hidaka, Saitama, Japan, 350-1298
Shizuoka Cancer Center
Sunto, Shizuoka, Japan, 411- 8777
Kouseiren Takaoka Hospital
Takaoka, Toyama, Japan, 933- 8555
National Kyusyu Cancer Center
Fukuoka, Japan, 811- 1395
Kochi Health Sciences Center
Kochi, Japan, 781- 855
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Study Chair: Nagahiro Saijo, MD Kinki University Hospital
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00661167     History of Changes
Other Study ID Numbers: Taiho10041040
Study First Received: April 16, 2008
Last Updated: January 16, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013