Phase II Study of ABI-007 for Gastric Cancer

This study is currently recruiting participants.

Verified by Taiho Pharmaceutical Co., Ltd., September 2009

First Received: April 16, 2008 Last Updated: September 3, 2009 History of Changes

Sponsored by:	Taiho Pharmaceutical Co., Ltd.
Information provided by:	Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00661167

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Stomach Cancer

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 ]

Estimated Enrollment:	53
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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

Contacts

Contact: Tomohiro Kanno

+81- 3- 3293- 2113

tom-kanno@taiho.co.jp

Locations

Japan
National Kyusyu Cancer Center	Recruiting
Fukuoka, Japan, 811- 1395
Contact: Yasushi Toh, MD +81- 92- 541- 3231
Kochi Health Sciences Center	Recruiting
Kochi, Japan, 781- 855
Contact: Akihito Tsuji, MD +81- 88- 837- 3000
Japan, Aichi
Aichi Cancer Center	Recruiting
Nagoya, Aichi, Japan, 464-8681
Contact: Kei Muro, MD +81- 52- 762- 6111
Japan, Ehime
Shikoku Cancer Center	Recruiting
Matsuyama, Ehime, Japan, 791- 0280
Contact: Hiroyuki Nishina, MD +81- 89- 999- 1111
Japan, Kanagawa
Kitasato University East Hospital	Recruiting
Sagamihara, Kanagawa, Japan, 228-8520
Contact: Wasaburo Koizumi, MD +81- 42- 748- 9111
Japan, Nagano
Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare	Recruiting
Saku, Nagano, Japan, 384-0301
Contact: Yoshinori Miyata, MD +81- 267- 82- 3131
Japan, Osaka
Osaka Medical College Hospital	Recruiting
Takatsuki, Osaka, Japan, 569- 8686
Contact: Hiroya Takiuchi, MD +81- 72- 683- 1221
Japan, Saitama
Saitama International medical center-comprehensive cancer center, Saitama Medical University	Recruiting
Hidaka, Saitama, Japan, 350-1298
Contact: Yasutsuna Sasaki, MD +81- 42- 984- 4111
Japan, Shizuoka
Shizuoka Cancer Center	Recruiting
Sunto, Shizuoka, Japan, 411- 8777
Contact: Hirofumi Yasui, MD +81- 55- 989- 5222
Japan, Toyama
Kouseiren Takaoka Hospital	Recruiting
Takaoka, Toyama, Japan, 933- 8555
Contact: Takuo Hara, MD +81- 766- 21- 3930

Sponsors and Collaborators

Taiho Pharmaceutical Co., Ltd.

Investigators

Study Chair:

Nagahiro Saijo, MD

National Cancer Center Hospital East

More Information

No publications provided

Responsible Party:	Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers:	Taiho10041040
Study First Received:	April 16, 2008
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00661167 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Antimitotic Agents
Recurrence
Digestive System Diseases
Stomach Diseases
Paclitaxel

Stomach Neoplasms
Fluorouracil
Tubulin Modulators
Gastrointestinal Neoplasms
Stomach Cancer
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:

Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gastrointestinal Diseases
Mitosis Modulators
Antimitotic Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Digestive System Diseases
Stomach Diseases
Paclitaxel
Therapeutic Uses
Stomach Neoplasms
Tubulin Modulators
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on September 11, 2009