Clincosm LogoSign in Get a demo

Phase II Study of ABI-007 for Gastric Cancer

Sponsor
Taiho Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT00661167
Collaborator
(none)
56
Enrollment
10
Locations
1
Arm
44
Duration (Months)
5.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
N/A
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 :
Apr 1, 2008
Actual Primary Completion Date :
May 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [During chemotherapy]

Secondary Outcome Measures

  1. Safety [During chemotherapy]

  2. Progression-free survival [Until progression]

  3. Overall survival [Over a year form randomaization]

  4. Disease control rate [Duration chemoterapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 74 Years
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Taiho Pharmaceutical Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00661167
Other Study ID Numbers:
  • Taiho10041040
First Posted:
Apr 18, 2008
Last Update Posted:
Jan 18, 2012
Last Verified:
Jan 1, 2012
Additional relevant MeSH terms:
Stomach Neoplasms
Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Jan 18, 2012