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Completed

NCT Number: NCT00661167

Phase II Study of ABI-007 for Gastric Cancer

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aichi Cancer Center, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Overall response rate

    Time frame: During chemotherapy

Secondary outcomes

  1. Safety

    Time frame: During chemotherapy

  2. Progression-free survival

    Time frame: Until progression

  3. Overall survival

    Time frame: Over a year form randomaization

  4. Disease control rate

    Time frame: Duration chemoterapy

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Apr 18, 2008
Registry last updated
Jan 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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