Phase II Study of ABI-007 for Gastric Cancer

NCT00661167 | Completed Phase 2 DMC

• 1 other identifier: Taiho10041040
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 10

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  During chemotherapy

Secondary Outcomes (4)

• Safety

  During chemotherapy

• Progression-free survival

  Until progression

• Overall survival

  Over a year form randomaization

• Disease control rate

  Duration chemoterapy

Study Arms (1)

1

EXPERIMENTAL

ABI-007

Drug: ABI-007

Interventions

ABI-007 DRUG

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

1

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (10)

Aichi Cancer Center

Nagoya, Aichi-ken, 464-8681, Japan

Location

Shikoku Cancer Center

Matsuyama, Ehime, 791- 0280, Japan

Location

National Kyusyu Cancer Center

Fukuoka, Fukuoka, 811- 1395, Japan

Location

Kitasato University East Hospital

Sagamihara, Kanagawa, 228-8520, Japan

Location

Kochi Health Sciences Center

Kochi, Kochi, 781- 855, Japan

Location

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

Saku, Nagano, 384-0301, Japan

Location

Osaka Medical College Hospital

Takatsuki, Osaka, 569- 8686, Japan

Location

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

Hidaka, Saitama, 350-1298, Japan

Location

Shizuoka Cancer Center

Sunto, Shizuoka, 411- 8777, Japan

Location

Kouseiren Takaoka Hospital

Takaoka, Toyama, 933- 8555, Japan

Location

Related Publications (1)

• 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.

  PMID: 24716542 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Nagahiro Saijo, MD

  Kinki University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2008
• First Posted: April 18, 2008
• Study Start: April 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 18, 2012

Record last verified: 2012-01

Locations

JP (10)