Study of Ixabepilone in Asian Subjects With Unresectable or Metastatic Gastric Cancer
NCT ID: NCT00983801
Last Updated: 2020-10-28
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2009-11-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ixabepilone
Ixabepilone
Vial, Injection, Intravenous (IV), 40 mg/m\^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.
Interventions
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Ixabepilone
Vial, Injection, Intravenous (IV), 40 mg/m\^2, Every 21 days, Up to 8 cycles or until disease progression or intolerable toxicity. Additional treatment was given in agreement by both the investigator and sponsor. Ixabepilone 40 mg/m\^2 was administered as a 3-hour IV infusion on Day 1 of each 21-day (3 week) cycle provided the participant met the retreatment criteria.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have unresectable or metastatic disease
* Asian ethnicity
* Must have failed prior fluoropyrimidine-based chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* measurable disease by with Response Evaluation Criteria in Solid Tumors (RECIST) guidelines
Exclusion Criteria
* Receipt of prior ixabepilone
* ECOG ≥2
* Known brain or meningeal metastasis
* Known viral hepatitis
* Prior taxane therapy
* Uncontrolled non-cancer related medical condition
* Second malignancy
* Peripheral neuropathy ≥ grade 2
* Inadequate hematologic, renal and hepatic function
18 Years
ALL
No
Sponsors
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R-Pharm
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Hong Kong, , Hong Kong
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Sunto-Gun, Shizuoka, Japan
Local Institution
Singapore, , Singapore
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan Hsien, , Taiwan
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA163-200
Identifier Type: -
Identifier Source: org_study_id