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Phase II Study of ABI-007 for Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00661167
Recruitment Status : Completed
First Posted : April 18, 2008
Last Update Posted : January 18, 2012
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: ABI-007 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : April 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: 1
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.

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: During chemotherapy ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: During chemotherapy ]
  2. Progression-free survival [ Time Frame: Until progression ]
  3. Overall survival [ Time Frame: Over a year form randomaization ]
  4. Disease control rate [ Time Frame: Duration chemoterapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00661167

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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.
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Study Chair: Nagahiro Saijo, MD Kinki University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Taiho Pharmaceutical Co., Ltd. Identifier: NCT00661167     History of Changes
Other Study ID Numbers: Taiho10041040
First Posted: April 18, 2008    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action