Back to resultsPhase II Study of ABI-007 for Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ABI-007
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility 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
Sites / Locations
- Aichi Cancer Center
- Shikoku Cancer Center
- Kitasato University East Hospital
- Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare
- Osaka Medical College Hospital
- Saitama International medical center-comprehensive cancer center, Saitama Medical University
- Shizuoka Cancer Center
- Kouseiren Takaoka Hospital
- National Kyusyu Cancer Center
- Kochi Health Sciences Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
ABI-007
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
Safety
Progression-free survival
Overall survival
Disease control rate
Full Information
NCT ID
NCT00661167
First Posted
April 16, 2008
Last Updated
January 16, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00661167
Brief Title
Phase II Study of ABI-007 for Gastric Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ABI-007
Intervention Type
Drug
Intervention Name(s)
ABI-007
Intervention Description
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 Measure Information:
Title
Overall response rate
Time Frame
During chemotherapy
Secondary Outcome Measure Information:
Title
Safety
Time Frame
During chemotherapy
Title
Progression-free survival
Time Frame
Until progression
Title
Overall survival
Time Frame
Over a year form randomaization
Title
Disease control rate
Time Frame
Duration chemoterapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagahiro Saijo, MD
Organizational Affiliation
Kinki University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Aichi Cancer Center
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791- 0280
Country
Japan
Facility Name
Kitasato University East Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8520
Country
Japan
Facility Name
Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare
City
Saku
State/Province
Nagano
ZIP/Postal Code
384-0301
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569- 8686
Country
Japan
Facility Name
Saitama International medical center-comprehensive cancer center, Saitama Medical University
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Shizuoka Cancer Center
City
Sunto
State/Province
Shizuoka
ZIP/Postal Code
411- 8777
Country
Japan
Facility Name
Kouseiren Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933- 8555
Country
Japan
Facility Name
National Kyusyu Cancer Center
City
Fukuoka
ZIP/Postal Code
811- 1395
Country
Japan
Facility Name
Kochi Health Sciences Center
City
Kochi
ZIP/Postal Code
781- 855
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
24716542
Citation
Sasaki Y, Nishina T, Yasui H, Goto M, Muro K, Tsuji A, Koizumi W, Toh Y, Hara T, Miyata Y. Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer. Cancer Sci. 2014 Jul;105(7):812-7. doi: 10.1111/cas.12419. Epub 2014 Jul 7.
Results Reference
derived
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Phase II Study of ABI-007 for Gastric Cancer
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