Phase II Study of ABI-007 for Gastric Cancer

NCT ID: NCT00661167

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

ABI-007

Group Type EXPERIMENTAL

ABI-007

Intervention Type DRUG

ABI-007 260 mg/m2, IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity develops.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nagahiro Saijo, MD

Role: STUDY_CHAIR

Kinki University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

Site Status

Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status

National Kyusyu Cancer Center

Fukuoka, Fukuoka, Japan

Site Status

Kitasato University East Hospital

Sagamihara, Kanagawa, Japan

Site Status

Kochi Health Sciences Center

Kochi, Kochi, Japan

Site Status

Saku Central Hospital Nagano Prefectural Federation of Agricultural Cooperatives for Health and Welfare

Saku, Nagano, Japan

Site Status

Osaka Medical College Hospital

Takatsuki, Osaka, Japan

Site Status

Saitama International medical center-comprehensive cancer center, Saitama Medical University

Hidaka, Saitama, Japan

Site Status

Shizuoka Cancer Center

Sunto, Shizuoka, Japan

Site Status

Kouseiren Takaoka Hospital

Takaoka, Toyama, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24716542 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Taiho10041040

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Study of ARQ 197 Monotherapy
NCT01152645 COMPLETED PHASE2